Relapsing Remitting Multiple SclerosisPhase 1MSREPAIRNCT01808885
Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.
A Phase 1 study testing olesoxime (TRO19622) in people with Relapsing Remitting Multiple Sclerosis, run by Hoffmann-La Roche at 3 sites in France.
Trial summary
This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- olesoxime (TRO19622)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2013to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years old
- Diagnosed with Relapsing Remitting Multiple Sclerosis. Patients must be stable defined as free from relapsing episode for at least 6 months prior to Baseline
- Patients must be treated with Interferon beta for at least one year
- Patients must have an Expanded Disability Status Scale (EDSS) score ≤ 5
- Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception for at least 3 months prior to Baseline and during the study. In addition, female patients must not be lactating
- Patients must be able to understand and comply with study requirements
- Patients must provide a written, dated and signed informed consent prior to any study procedure
Who cannot join
- Any relapse of multiple sclerosis within the past 6 months prior to Screening Visit/Visit -1
- Any change in Interferon treatment within the past year prior to Screening Visit (Visit -1)
- Expected use of another disease modifying therapy from Screening Visit/Visit -1 to Visit 3/Final Visit
- Patients unable to undergo MRI scan
- Current or expected use of a medication that could interfere with olesoxime pharmacology (e.g. tamoxifen)
- Current or expected use of lipid lowering agents (ezetimibe, bile salt chelators, fibrates, phytosterols) other than statins
Show all 23Show fewer
- Known hypersensitivity to olesoxime or any of its components
- History of alcohol or drug abuse within the last 6 months, or addiction within the last 2 years prior to Baseline Visit
- Positive urinary pregnancy test at Baseline Visit
- History of hepatitis B/C or HIV positive serology
- Hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> 3 × ULN) at Baseline Visit
- History of renal impairment defined by a serum creatinine value > 176 μmol/L (2.0 mg/dL) at Baseline Visit
- Abnormal and clinically significant ECG at Screening Visit/Visit -1 as assessed by a cardiologist
- Current or expected use of oral or intramuscular corticosteroids within 3 months prior to the Screening Visit. Only stable dose regimens of inhaled and topical corticosteroids are allowed during the study
- History of any clinically relevant gastrointestinal (GI), respiratory, psychiatric, neurological, kidney, liver, cardiac diseases, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives or put the patient's safety at risk, as judged by the Investigator
- Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than Multiple Sclerosis (MS)
- History of malignancy of any organ, treated or non-treated within the past 5 years
- Current participation or participation within 30 days prior to study entry, in another investigational drug or device study, or previous enrolment in the present study
- Any direct involvement with the study conduct at site or any family link with study site staff
- Pregnant, parturient or lactating women, as per Public Health Code (CSP)(Article L-1121-5)
- Persons deprived of their liberty by a judicial or administrative decision, and those admitted to a health or social facility, as per CSP (Article L-1121-6)
- Persons covered by a measure of legal protection or unable to provide a written, dated and signed informed consent, as per CSP(Article L-1121-8)
- Patient without Social Security Insurance
Trial locations and contacts
3 sites in 1 country.
France3 sites
Timone University Hospital, Neurology Department, UMR CRMBM CNRS 6612
Marseille, 13385
CHU Reims, Maison Blanche Hospital, Neurology Department & University of Reims
Reims, 51092
CHU Pontchaillou, Neurology Department
Rennes, 35033
About this study
Official title: A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.
This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.
Read the detailed description
The primary objective of this study is to characterize the general safety and tolerability of olesoxime (495 mg, od), compared to placebo when administered in combination with Interferon beta over a 24-week treatment period in patients with stable Relapsing Remitting Multiple Sclerosis.
The secondary objective of this study is to evaluate the feasibility of multicenter protocols for measurement of neurodegeneration and remyelination by MRI as well as the plasma exposure to olesoxime (495 mg, od).
MRI will be performed to all patients to assess effects of olesoxime on brain inflammation as well as to assess measures of brain atrophy, neuronal damage and myelination status at Baseline, 12 weeks and 24 weeks.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- olesoxime (TRO19622), placebo
- Keywords
- safety, multiple sclerosis, olesoxime, double-blind, randomized
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olesoxime (TRO19622)Drug
Also called TRO19622 (olesoxime)
olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months.
Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit).
placeboDrug
placebo capsule shells with identical appearance as the active compound TRO19622
| Study group | Role | What they receive |
|---|---|---|
| olesoxime (TRO19622) | Experimental | olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months.
Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit). Receives: Drug: olesoxime (TRO19622) |
| placebo | Placebo comparator | placebo (3 soft capsules, od) will be administered orally for 6 months Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety criteria
Cumulative incidence of adverse events/serious adverse events (i.e. total number per patient) as assessed by ongoing monitoring.
Measured: The primary endpoint of this study will be the cumulative incidence of AE/SAE assessed by ongoing monitoring at week 24 (day 168)
Secondary outcomes (1)
MRI Parameters
- Number of Gadolinium-enhancing lesions on T1-weighted images
- Number of new or enlarged lesions on T2-weighted images
Measured: Baseline (Visit 0), Week 12 (Visit 2) and Week 24 (Visit 3/Final Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hôpital de la Timone, SGS S.A., STRAGEN Services
- Responsible party
- Sponsor
- Investigators
- Jean PELLETIER, MD, Principal investigator, Head of Neurology Department, UMR CRMBM CNRS 6612, Timone University Hospital, Marseille, FranceAyman TOURBAH, MD, Principal investigator, Professor of Neurology, Neurology Department & University of ReimsGilles EDAN, MD, Principal investigator, Professor of Clinical Neurology, Head of Neurology Department, Pontchaillou Hospital, Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808885
- Sponsor's protocol ID
- WP29866
- Other IDs
- 2012-005186-12, TRO19622CLEQ1585-1
- Acronym
- MSREPAIR
- Status last verified
- Nov 2016
- First submitted
- 12 Feb 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.
- ClinicalTrials.gov ID
- NCT01808885
- Acronym / sponsor ID
- MSREPAIR / WP29866
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- safety, multiple sclerosis, olesoxime, double-blind, randomized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Hôpital de la Timone, SGS S.A., STRAGEN Services
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Mar 2013 (estimated)
- 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.
This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.
Detailed description
The primary objective of this study is to characterize the general safety and tolerability of olesoxime (495 mg, od), compared to placebo when administered in combination with Interferon beta over a 24-week treatment period in patients with stable Relapsing Remitting Multiple Sclerosis.
The secondary objective of this study is to evaluate the feasibility of multicenter protocols for measurement of neurodegeneration and remyelination by MRI as well as the plasma exposure to olesoxime (495 mg, od).
MRI will be performed to all patients to assess effects of olesoxime on brain inflammation as well as to assess measures of brain atrophy, neuronal damage and myelination status at Baseline, 12 weeks and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olesoxime (TRO19622) | Experimental | Drug: olesoxime (TRO19622)olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months. Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit). |
| placebo | Placebo comparator | Drug: placeboplacebo (3 soft capsules, od) will be administered orally for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥ 18 years old
- Diagnosed with Relapsing Remitting Multiple Sclerosis. Patients must be stable defined as free from relapsing episode for at least 6 months prior to Baseline
- Patients must be treated with Interferon beta for at least one year
- Patients must have an Expanded Disability Status Scale (EDSS) score ≤ 5
- Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception for at least 3 months prior to Baseline and during the study. In addition, female patients must not be lactating
Key exclusion criteria (23 listed)
- Any relapse of multiple sclerosis within the past 6 months prior to Screening Visit/Visit -1
- Any change in Interferon treatment within the past year prior to Screening Visit (Visit -1)
- Expected use of another disease modifying therapy from Screening Visit/Visit -1 to Visit 3/Final Visit
- Patients unable to undergo MRI scan
- Current or expected use of a medication that could interfere with olesoxime pharmacology (e.g. tamoxifen)
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 |
|---|---|---|
| olesoxime (TRO19622)Also: TRO19622 (olesoxime)olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months. Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit). | Drug | olesoxime (TRO19622) |
| placeboplacebo capsule shells with identical appearance as the active compound TRO19622 | Drug | placebo |
Primary outcome
Safety criteria
Time frame: The primary endpoint of this study will be the cumulative incidence of AE/SAE assessed by ongoing monitoring at week 24 (day 168)
Cumulative incidence of adverse events/serious adverse events (i.e. total number per patient) as assessed by ongoing monitoring.
1 secondary outcome
MRI Parameters
Time frame: Baseline (Visit 0), Week 12 (Visit 2) and Week 24 (Visit 3/Final Visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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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. This study is not recruiting at the moment.
Jean PELLETIER, MD principal investigator
Head of Neurology Department, UMR CRMBM CNRS 6612, Timone University Hospital, Marseille, France
Ayman TOURBAH, MD principal investigator
Professor of Neurology, Neurology Department & University of Reims
Gilles EDAN, MD principal investigator
Professor of Clinical Neurology, Head of Neurology Department, Pontchaillou Hospital, Rennes, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing olesoxime (TRO19622) in people with Relapsing Remitting Multiple Sclerosis, run by Hoffmann-La Roche at 3 sites in France.
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 7 inclusion and 23 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: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety criteria (time frame: The primary endpoint of this study will be the cumulative incidence of AE/SAE assessed by ongoing monitoring at week 24 (day 168)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2016.