Multiple Sclerosis (MS)Phase 1/2ReVIVENCT05359653
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
A Phase 1/2 study testing Clemastine Fumarate in people with Multiple Sclerosis (MS) and Multiple Sclerosis, Relapsing-Remitting, run by University of California, San Francisco at 1 site in United States.
Trial summary
The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis (MS), Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive
- What is being tested?
- Clemastine Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent must be obtained prior to any assessment being performed.
- Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of < 15 years
- Male or female patients aged 18-55 years (inclusive)
- Use of appropriate contraception during period of trial (women). Before entry women must be:
- Post-menopausal for at least 1 year OR
- Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, male partner vasectomy or otherwise incapable of pregnancy) OR
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- Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study OR
- Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) OR
- Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) is not an acceptable method.
Who cannot join
- Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI
- New lesion in most recent MRI (within 3 months)
- Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.
- Treatment with corticosteroids within 30 days prior to screening.
- Expanded Disability Status Scale (EDSS) ≥ 4.5
- History of significant cardiac conduction block.
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- History of cancer.
- Suicidal ideation or behavior in 6 months prior to baseline.
- Pregnancy, breastfeeding or planning to become pregnant.
- Involved with other study protocols simultaneously without prior approval.
- Concomitant use of any other putative remyelinating therapy as determined by the investigator.
- Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.
- Prior treatment with alemtuzumab, mitoxantrone, or cyclophosphamide.
- Serum creatinine > 1.5 mg/dL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase > 2 times the upper limit of normal. (Reported within 72 hours)
- History of drug or alcohol abuse within the past year.
- Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid [MMA] and homocysteine) or untreated hypothyroidism.
- Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety.
- History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study
- Inability to participate in MRI, including extreme claustrophobia.
- Any dental braces or permanent or undetachable metals in the jaw or face.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sandler Neurosciences Building, Neurological Clinical Research Unit
San Francisco, California, 94107
Harkeerat Halait, BS, 415-745-1304, Harkeerat.Halait@ucsf.edu
Angelica Montevirgen, BS, 415-745-1304, Angelica.Montevirgen@ucsf.edu
About this study
Official title: A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments.
No reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.
Read more
This study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis.
In addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.
Read the detailed description
Treatments capable of remyelination are a major unmet need for multiple sclerosis and other diseases that involve myelin damage, loss, or dysfunction in the central nervous system (CNS). Chronic demyelination of axons is believed to be injurious to neurons and serves as a major contributor to irreversible cell loss that underlies permanent disability. Available MS treatments are primarily immunosuppressing, without directly addressing or fully preventing axonal degeneration and disability. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at UCSF. The screen demonstrated that clemastine promoted the differentiation of the endogenous oligodendrocyte precursor cells (OPCs) into mature myelinating oligodendrocytes. Following in vivo validation, an FDA investigational new drug (IND) exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.
This clinical trial is intended to assess magnetic resonance imaging evidence of remyelination using Clemastine Fumarate in patients with chronic demyelinated lesions. Specifically speaking, the primary objective will assess various multi-parametric MRI sequences on the corpus callosum region, a region that animal models studies identified as a promising candidate for assessing remyelination. The aim was to help define the potential for MRI in measuring remyelination in MS, determine the optimal sequences and location for measuring myelin recovery, and help guide trial design for future remyelinating trials. Finally, the study is designed to assess tolerability and clinical efficacy of Clemastine using outcomes intended to assess for (a) adverse events and (b) recovery of myelin.
- Conditions
- Multiple Sclerosis (MS), Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis Relapse, Multiple Sclerosis Brain Lesion
- Being tested
- Clemastine Fumarate, Placebo
- Keywords
- multiple sclerosis, mri, brain, spinal cord
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clemastine FumarateDrug
Also called Clemastine, Dayhist, Dayhist Allergy
8 mg Clemastine tablet. Clemastine fumarate was approved by the Food and Drug Administration (FDA) for the treatment of allergic rhinitis (seasonal allergies) in 1977 and was approved for over-the-counter marketing in 1992. Clemastine is not FDA approved as a remyelinating therapy
PlaceboDrug
Also called Sugar pill
Matched sugar tablet
| Study group | Role | What they receive |
|---|---|---|
| Clemastine 8 mg, then Placebo | Experimental | Group 1 will receive the treatment (clemastine 8mg/day) for the first 90 days and then switch to the placebo (a sugar pill) for the remaining 90 days Receives: Drug: Clemastine Fumarate; Drug: Placebo |
| Placebo, then Clemastine 8 mg | Experimental | Group 2 will receive the placebo (a sugar pill) for the first 90 days and then switch to the treatment (clemastine 8mg/day) for the remaining 90 days Receives: Drug: Clemastine Fumarate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corpus Callosum Myelin Water Fraction
The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months
The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months
The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Corpus Callosum T1 Relaxation Time
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 Months
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (3-month time - Baseline time)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corpus Callosum T1 Relaxation Time at 6 Months
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (6-month time - Baseline time)
Measured: This will be assessed at the baseline and 6-month visits.
Corpus Callosum UTE Fraction
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Corpus Callosum UTE Fraction at 3 Months
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corpus Callosum UTE Fraction at 6 Months
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Secondary outcomes (42)
Optic Radiation Myelin Water Fraction
The efficacy of Clemastine relative to placebo at increasing the MWF (measured in %) of the optic radiation.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Optic Radiation Myelin Water Fraction at 3 Months
The efficacy of clemastine relative to placebo at increasing the MWF (measured in %) of the optic radiation. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Optic Radiation Myelin Water Fraction at 6 Months
The efficacy of clemastine relative to placebo at increasing the MWF (measured in %) of the optic radiation. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Corticospinal Tract Myelin Water Fraction
The efficacy of clemastine relative to placebo at increasing the MWF (measured in %) of the corticospinal tract.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Corticospinal Tract Myelin Water Fraction at 3 Months
The efficacy of clemastine relative to placebo at increasing the MWF (measured in %) of the corticospinal tract. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corticospinal Tract Myelin Water Fraction at 6 Months
The efficacy of clemastine relative to placebo at increasing the MWF (measured in %) of the corticospinal tract. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Optic Radiation T1 Relaxation time
To evaluate the efficacy of Clemastine relative to placebo at increasing the T1 relaxation time (measured in seconds) of the optic radiation.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Optic Radiation T1 Relaxation Time at 3 Months
To evaluate the efficacy of Clemastine relative to placebo at increasing the T1 relaxation time (measured in seconds) of the optic radiation. Change = (3-month time - Baseline time)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Optic Radiation T1 Relaxation Time at 6 Months
To evaluate the efficacy of Clemastine relative to placebo at increasing the T1 relaxation time (measured in seconds) of the optic radiation. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Corticospinal Tract T1 Relaxation Time
To evaluate the efficacy of Clemastine relative to placebo at increasing the T1 relaxation time (measured in seconds) of the corticospinal tract.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Corticospinal T1 Relaxation Time at 3 Months
To evaluate the efficacy of Clemastine relative to placebo at increasing the T1 relaxation time (measured in seconds) of the corticospinal tract. Change = (3-month time - Baseline time)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corticospinal Tract T1 Relaxation Time at 6 Months
To evaluate the efficacy of Clemastine relative to placebo at increasing the T1 relaxation time (measured in seconds) of the corticospinal tract. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Optic radiation UTE Fraction
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) of the optic radiation.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Optic radiation UTE Fraction at 3 Months
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) of the optic radiation. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Optic radiation UTE Fraction at 6 Months
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) of the optic radiation. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Corticospinal Tract UTE Fraction
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) of the corticospinal tract.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Corticospinal Tract UTE Fraction at 3 Months
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) of the corticospinal tract. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corticospinal Tract UTE Fraction at 6 Months
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) of the corticospinal tract. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Lesion of interest (LOI) MWF
The efficacy of clemastine relative to placebo at increasing MWF (measured in %) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs.
Measured: This will be assessed at the baseline visit.
Change from Baseline in LOI MWF at 3 Months
The efficacy of clemastine relative to placebo at increasing MWF (measured in %) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in LOI MWF at 6 Months
The efficacy of clemastine relative to placebo at increasing MWF (measured in %) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
LOI T1 Relaxation Time
The efficacy of clemastine relative to placebo at increasing T1 relaxation time (measured in seconds) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs.
Measured: This will be assessed at the baseline visit.
Change from Baseline in LOI T1 Relaxation Time at 3 Months
The efficacy of clemastine relative to placebo at increasing T1 relaxation time (measured in seconds) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs. Change = (3-month time - Baseline time)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in LOI T1 Relaxation Time at 6 Months
The efficacy of clemastine relative to placebo at increasing T1 relaxation time (measured in seconds) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs. Change = (6-month time - Baseline time)
Measured: This will be assessed at the baseline and 6-month visits.
LOI UTE Fraction
The efficacy of clemastine relative to placebo at increasing UTE fraction (measured in %) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs.
Measured: This will be assessed at the baseline visit.
Change from Baseline in LOI UTE Fraction at 3 Months
The efficacy of clemastine relative to placebo at increasing UTE fraction (measured in %) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in LOI UTE Fraction at 6 Months
The efficacy of clemastine relative to placebo at increasing UTE fraction (measured in %) of the lesion(s) of interest, stratified based on enhancement status on prior MRIs. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Whole Brain MWF
The efficacy of clemastine relative to placebo at increasing MWF (measured in %) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Whole Brain MWF at 3 Months
The efficacy of clemastine relative to placebo at increasing MWF (measured in %) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Whole Brain MWF at 6 Months
The efficacy of clemastine relative to placebo at increasing MWF (measured in %) values across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Whole Brain T1 Relaxation Time
The efficacy of clemastine relative to placebo at increasing T1 relaxation time (measured in seconds) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Whole Brain T1 Relaxation Time at 3 Months
The efficacy of clemastine relative to placebo at increasing T1 relaxation time (measured in seconds) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter. Change = (3-month time - Baseline time)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Whole Brain T1 Relaxation Time at 6 Months
The efficacy of clemastine relative to placebo at increasing T1 relaxation time (measured in seconds) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter. Change = (6-month time - Baseline time)
Measured: This will be assessed at the baseline and 6-month visits.
Whole Brain UTE Fraction
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Whole Brain UTE Values at 3 Months
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter. Change = (3-month % - Baseline %)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Whole Brain UTE Values at 6 Months
The efficacy of clemastine relative to placebo at increasing the UTE fraction (measured in %) across the whole-brain divided into regions of normal-appearing white matter (NAWM), cortical gray matter, and deep gray matter. Change = (6-month % - Baseline %)
Measured: This will be assessed at the baseline and 6-month visits.
Clemastine Tolerability
The tolerability of Clemastine in this population. This will include a special focus with regards to fatigue as this is a major symptom for patients suffering from multiple sclerosis.
Measured: This will be assessed at the baseline visit.
Change from Baseline in Clemastine Tolerability at 3 Months
The tolerability of Clemastine in this population. This will include a special focus with regards to fatigue as this is a major symptom for patients suffering from multiple sclerosis. Change = (3-month tolerability - Baseline tolerability)
Measured: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Clemastine Tolerability at 6 Months
The tolerability of Clemastine in this population. This will include a special focus with regards to fatigue as this is a major symptom for patients suffering from multiple sclerosis. Change = (6-month tolerability - Baseline tolerability)
Measured: This will be assessed at the baseline and 6-month visits.
Informative Outcomes
Which secondary or tertiary outcomes are likely to be informative for future remyelinating trials in optic neuritis (and other related indications).
Measured: This will be assessed at the baseline visit.
Informative Outcomes at 3 Months
Which secondary or tertiary outcomes are likely to be informative for future remyelinating trials in optic neuritis (and other related indications).
Measured: This will be assessed at the 3-month visit.
Informative Outcomes at 6 Months
Which secondary or tertiary outcomes are likely to be informative for future remyelinating trials in optic neuritis (and other related indications).
Measured: This will be assessed at the 6-month visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Aug 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 6-month randomized double-blinded, placebo-controlled, delayed treatment study examining clemastine fumarate as a remyelinating agent in participants with multiple sclerosis. This trial will include n = 74 patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis. Patients who fulfill the enrollment criteria will be randomly assigned (1:1) via block randomization using a random number generator to receive either clemastine for 90 days followed by placebo for 90 days (Clemastine 8 mg, then Placebo) or placebo for 90 days followed by clemastine for 90 days (Placebo, then Clemastine 8 mg). If they are on one, patients will be permitted to remain on their standard disease-modifying treatment during the course of the study. These therapies have no identified effect on remyelination.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Ari J Green, MD, MCR, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359653
- Sponsor's protocol ID
- 22-36052
- Acronym
- ReVIVE
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mei F, Fancy SPJ, Shen YA, Niu J, Zhao C, Presley B, Miao E, Lee S, Mayoral SR, Redmond SA, Etxeberria A, Xiao L, Franklin RJM, Green A, Hauser SL, Chan JR. Micropillar arrays as a high-throughput screening platform for therapeutics in multiple sclerosis. Nat Med. 2014 Aug;20(8):954-960. doi: 10.1038/nm.3618. Epub 2014 Jul 6.
PubMed 24997607Marques JP, Kober T, Krueger G, van der Zwaag W, Van de Moortele PF, Gruetter R. MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field. Neuroimage. 2010 Jan 15;49(2):1271-81. doi: 10.1016/j.neuroimage.2009.10.002. Epub 2009 Oct 9.
PubMed 19819338Sheth V, Shao H, Chen J, Vandenberg S, Corey-Bloom J, Bydder GM, Du J. Magnetic resonance imaging of myelin using ultrashort Echo time (UTE) pulse sequences: Phantom, specimen, volunteer and multiple sclerosis patient studies. Neuroimage. 2016 Aug 1;136:37-44. doi: 10.1016/j.neuroimage.2016.05.012. Epub 2016 May 5.
PubMed 27155128Green AJ, Gelfand JM, Cree BA, Bevan C, Boscardin WJ, Mei F, Inman J, Arnow S, Devereux M, Abounasr A, Nobuta H, Zhu A, Friessen M, Gerona R, von Budingen HC, Henry RG, Hauser SL, Chan JR. Clemastine fumarate as a remyelinating therapy for multiple sclerosis (ReBUILD): a randomised, controlled, double-blind, crossover trial. Lancet. 2017 Dec 2;390(10111):2481-2489. doi: 10.1016/S0140-6736(17)32346-2. Epub 2017 Oct 10.
PubMed 29029896Gagliardo A, Galli F, Grippo A, Amantini A, Martinelli C, Amato MP, Borsini W. Motor evoked potentials in multiple sclerosis patients without walking limitation: amplitude vs. conduction time abnormalities. J Neurol. 2007 Feb;254(2):220-7. doi: 10.1007/s00415-006-0334-5. Epub 2007 Feb 17.
PubMed 17308868
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
- ClinicalTrials.gov ID
- NCT05359653
- Acronym / sponsor ID
- ReVIVE / 22-36052
- Conditions
- Multiple Sclerosis (MS), Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis Relapse, Multiple Sclerosis Brain Lesion
- Keywords
- multiple sclerosis, mri, brain, spinal cord
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments.
No reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.
This study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis.
In addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.
Detailed description
Treatments capable of remyelination are a major unmet need for multiple sclerosis and other diseases that involve myelin damage, loss, or dysfunction in the central nervous system (CNS). Chronic demyelination of axons is believed to be injurious to neurons and serves as a major contributor to irreversible cell loss that underlies permanent disability. Available MS treatments are primarily immunosuppressing, without directly addressing or fully preventing axonal degeneration and disability. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at UCSF. The screen demonstrated that clemastine promoted the differentiation of the endogenous oligodendrocyte precursor cells (OPCs) into mature myelinating oligodendrocytes. Following in vivo validation, an FDA investigational new drug (IND) exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.
This clinical trial is intended to assess magnetic resonance imaging evidence of remyelination using Clemastine Fumarate in patients with chronic demyelinated lesions. Specifically speaking, the primary objective will assess various multi-parametric MRI sequences on the corpus callosum region, a region that animal models studies identified as a promising candidate for assessing remyelination. The aim was to help define the potential for MRI in measuring remyelination in MS, determine the optimal sequences and location for measuring myelin recovery, and help guide trial design for future remyelinating trials. Finally, the study is designed to assess tolerability and clinical efficacy of Clemastine using outcomes intended to assess for (a) adverse events and (b) recovery of myelin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 6-month randomized double-blinded, placebo-controlled, delayed treatment study examining clemastine fumarate as a remyelinating agent in participants with multiple sclerosis. This trial will include n = 74 patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis. Patients who fulfill the enrollment criteria will be randomly assigned (1:1) via block randomization using a random number generator to receive either clemastine for 90 days followed by placebo for 90 days (Clemastine 8 mg, then Placebo) or placebo for 90 days followed by clemastine for 90 days (Placebo, then Clemastine 8 mg). If they are on one, patients will be permitted to remain on their standard disease-modifying treatment during the course of the study. These therapies have no identified effect on remyelination.
| Arm | Type | Receives |
|---|---|---|
| Clemastine 8 mg, then Placebo | Experimental | Drug: Clemastine Fumarate, Drug: PlaceboGroup 1 will receive the treatment (clemastine 8mg/day) for the first 90 days and then switch to the placebo (a sugar pill) for the remaining 90 days |
| Placebo, then Clemastine 8 mg | Experimental | Drug: Clemastine Fumarate, Drug: PlaceboGroup 2 will receive the placebo (a sugar pill) for the first 90 days and then switch to the treatment (clemastine 8mg/day) for the remaining 90 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Written informed consent must be obtained prior to any assessment being performed.
- Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of < 15 years
- Male or female patients aged 18-55 years (inclusive)
- Use of appropriate contraception during period of trial (women). Before entry women must be:
Key exclusion criteria (20 listed)
- Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI
- New lesion in most recent MRI (within 3 months)
- Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.
- Treatment with corticosteroids within 30 days prior to screening.
- Expanded Disability Status Scale (EDSS) ≥ 4.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clemastine FumarateAlso: Clemastine, Dayhist, Dayhist Allergy8 mg Clemastine tablet. Clemastine fumarate was approved by the Food and Drug Administration (FDA) for the treatment of allergic rhinitis (seasonal allergies) in 1977 and was approved for over-the-counter marketing in 1992. Clemastine is not FDA approved as a remyelinating therapy | Drug | Clemastine 8 mg, then Placebo, Placebo, then Clemastine 8 mg |
| PlaceboAlso: Sugar pillMatched sugar tablet | Drug | Clemastine 8 mg, then Placebo, Placebo, then Clemastine 8 mg |
Primary outcome
Corpus Callosum Myelin Water Fraction
Time frame: This will be assessed at the baseline visit.
The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum.
Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)
Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)
Corpus Callosum T1 Relaxation Time
Time frame: This will be assessed at the baseline visit.
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI.
Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (3-month time - Baseline time)
Change from Baseline in Corpus Callosum T1 Relaxation Time at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (6-month time - Baseline time)
Corpus Callosum UTE Fraction
Time frame: This will be assessed at the baseline visit.
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum.
Change from Baseline in Corpus Callosum UTE Fraction at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)
Change from Baseline in Corpus Callosum UTE Fraction at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)
42 secondary outcomes
Optic Radiation Myelin Water Fraction
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Optic Radiation Myelin Water Fraction at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Optic Radiation Myelin Water Fraction at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Corticospinal Tract Myelin Water Fraction
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Corticospinal Tract Myelin Water Fraction at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corticospinal Tract Myelin Water Fraction at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Optic Radiation T1 Relaxation time
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Optic Radiation T1 Relaxation Time at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Optic Radiation T1 Relaxation Time at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Corticospinal Tract T1 Relaxation Time
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Corticospinal T1 Relaxation Time at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corticospinal Tract T1 Relaxation Time at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Optic radiation UTE Fraction
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Optic radiation UTE Fraction at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Optic radiation UTE Fraction at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Corticospinal Tract UTE Fraction
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Corticospinal Tract UTE Fraction at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corticospinal Tract UTE Fraction at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Lesion of interest (LOI) MWF
Time frame: This will be assessed at the baseline visit.
Change from Baseline in LOI MWF at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in LOI MWF at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
LOI T1 Relaxation Time
Time frame: This will be assessed at the baseline visit.
Change from Baseline in LOI T1 Relaxation Time at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in LOI T1 Relaxation Time at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
LOI UTE Fraction
Time frame: This will be assessed at the baseline visit.
Change from Baseline in LOI UTE Fraction at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in LOI UTE Fraction at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Whole Brain MWF
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Whole Brain MWF at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Whole Brain MWF at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Whole Brain T1 Relaxation Time
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Whole Brain T1 Relaxation Time at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Whole Brain T1 Relaxation Time at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Whole Brain UTE Fraction
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Whole Brain UTE Values at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Whole Brain UTE Values at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Clemastine Tolerability
Time frame: This will be assessed at the baseline visit.
Change from Baseline in Clemastine Tolerability at 3 Months
Time frame: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Clemastine Tolerability at 6 Months
Time frame: This will be assessed at the baseline and 6-month visits.
Informative Outcomes
Time frame: This will be assessed at the baseline visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 24997607Mei F, Fancy SPJ, Shen YA, Niu J, Zhao C, Presley B, Miao E, Lee S, Mayoral SR, Redmond SA, Etxeberria A, Xiao L, Franklin RJM, Green A, Hauser SL, Chan JR. Micropillar arrays as a high-throughput screening platform for therapeutics in multiple sclerosis. Nat Med. 2014 Aug;20(8):954-960. doi: 10.1038/nm.3618. Epub 2014 Jul 6.
- Background: PubMed 19819338Marques JP, Kober T, Krueger G, van der Zwaag W, Van de Moortele PF, Gruetter R. MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field. Neuroimage. 2010 Jan 15;49(2):1271-81. doi: 10.1016/j.neuroimage.2009.10.002. Epub 2009 Oct 9.
- Background: PubMed 27155128Sheth V, Shao H, Chen J, Vandenberg S, Corey-Bloom J, Bydder GM, Du J. Magnetic resonance imaging of myelin using ultrashort Echo time (UTE) pulse sequences: Phantom, specimen, volunteer and multiple sclerosis patient studies. Neuroimage. 2016 Aug 1;136:37-44. doi: 10.1016/j.neuroimage.2016.05.012. Epub 2016 May 5.
- Background: PubMed 29029896Green AJ, Gelfand JM, Cree BA, Bevan C, Boscardin WJ, Mei F, Inman J, Arnow S, Devereux M, Abounasr A, Nobuta H, Zhu A, Friessen M, Gerona R, von Budingen HC, Henry RG, Hauser SL, Chan JR. Clemastine fumarate as a remyelinating therapy for multiple sclerosis (ReBUILD): a randomised, controlled, double-blind, crossover trial. Lancet. 2017 Dec 2;390(10111):2481-2489. doi: 10.1016/S0140-6736(17)32346-2. Epub 2017 Oct 10.
- Background: PubMed 17308868Gagliardo A, Galli F, Grippo A, Amantini A, Martinelli C, Amato MP, Borsini W. Motor evoked potentials in multiple sclerosis patients without walking limitation: amplitude vs. conduction time abnormalities. J Neurol. 2007 Feb;254(2):220-7. doi: 10.1007/s00415-006-0334-5. Epub 2007 Feb 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ari J Green, MD, MCR principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clemastine Fumarate in people with Multiple Sclerosis (MS) and Multiple Sclerosis, Relapsing-Remitting, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harkeerat Halait, BS (415-745-1304, Harkeerat.Halait@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corpus Callosum Myelin Water Fraction (time frame: This will be assessed at the baseline visit.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359653, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.