Multiple SclerosisNCT04593082
Obesity and Pediatric Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of Virginia at 2 sites in United States.
Trial summary
Obesity is one possible contributor to severity of multiple sclerosis and progression of the disease. We already know that obesity is a risk determinant for acquiring MS, yet the impact of obesity on pediatric MS disease expression and course is unknown. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 116 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2021to 1 Jun 2027
- Phase
- Observational
- 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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will be draw from outpatient clinics at UVA and CHOP as well as the surrounding communities for each institution. Subjects will be screened for eligibility to include BMI measurements at time of study discussion if they are interested.
Who may be able to join
- Ability to provide informed consent (or assent for minors)
- Relapsing-remitting MS diagnosis per 2017 McDonald criteria
- Ages ≥ 10 years to ≤ 20 years
- Diagnosis of MS or first clinical symptom of MS (whichever comes first) within ≤ 36 months from the time of enrollment.
- Ability to provide informed consent (or assent for minors)
- Age-, sex-, \& BMI-matched to pediatric MS subjects (1:1 allocation)
- Healthy children and young adults from the local communities
Who cannot join
- Progressive form of MS
- Patients with an active, chronic disease of the immune system other than MS
- Conditions affecting the central nervous system (CNS) white matter (e.g. leukodystrophy) or for whom another condition may better explain imaging abnormalities (e.g. lupus)
- Myelin oligodendrocyte glycoprotein (MOG) antibodies on serologic testing
- Corticosteroid exposure within 30 days of study enrollment
- Control subjects (Aim 2) will meet the below inclusion and exclusion criteria:
- History of past imaging or neurologic event raising concern for any inflammatory CNS process
- Medical history or previous/current diagnosis consistent with an autoimmune disorder pertaining to any system of the body (e.g. diabetes mellitus type 1, Crohn's disease, lupus)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22903
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
Obesity is one possible contributor to severity of multiple sclerosis and progression of the disease. We already know that obesity is a risk determinant for acquiring MS, yet the impact of obesity on pediatric MS disease expression and course is unknown. This study will evaluate the relationship between obesity, obesity-derived inflammatory mediators, and imaging metrics of MS severity in children. Understanding how childhood obesity contributes to MS severity/progression may yield fundamental insights into disease pathobiology - which may thereby lead to effective strategies for halting its progression in its earliest stages.
- Conditions
- Multiple Sclerosis
- Keywords
- Pediatric, Obesity, Neurodegeneration, Inflammation
- Medical subject headings
- Multiple Sclerosis, Obesity, Nerve Degeneration, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric MS Subjects | Subjects with pediatric MS will undergo fasting lab work, non-contrasted MRI, DEXA scan, and surveys. | |
| Healthy controls | Non-MS pediatric control subjects who will undergo fasting lab work, DEXA scan, and surveys for comparison to control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole brain volumes and focal demyelinating lesion volumes
58 patients with a recent MS diagnosis, stratified by weight category (29 normal weight and 29 overweight/obese). Subjects will undergo MRI to quantify total brain and lesion volume. Z-scores for volumetrics will be determined using age- and sex-matched normative data from the NIH-sponsored ABCD dataset. We will compare mean Z-scores of whole brain volume and focal demyelinating lesion volumes between the two groups.
Measured: 3 years
Secondary outcomes (2)
Adipo-cytokine profiles
Fasting adipo-cytokines from MS cohort will be compared to age-, sex-, and BMI-matched controls.
Measured: 3 years
Adipo-cytokines correlation with brain volume loss and neuroaxonal injury
We will measure serum NfL in MS subjects and controls. We will determine if leptin (a pro-inflammatory adipo-cytokine) predicts degree of brain volume loss and/or neuroaxonal injury in subjects with MS. This exploratory, mechanistic aim has potential to provide the first link between obesity-derived inflammation and neuronal cell injury/loss.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start3 Jun 2021
- Primary completion21 May 2026 (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 (20)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, J. Nicholas Brenton, MD, University of Virginia
- Investigators
- J Nicholas Brenton, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593082
- Sponsor's protocol ID
- HSR200257
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brenton JN, Koenig S, Goldman MD. Vitamin D status and age of onset of demyelinating disease. Mult Scler Relat Disord. 2014 Nov;3(6):684-8. doi: 10.1016/j.msard.2014.07.004. Epub 2014 Jul 28.
PubMed 25891547Woolbright EB, Brenton JN. Attitudes toward obestity and diet modification in pediatric MS patients. Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS); February, 28 2020, 2019; West Palm Beach, FL.
Brenton JN, Woolbright E, Briscoe-Abath C, Qureshi A, Conaway M, Goldman MD. Body mass index trajectories in pediatric multiple sclerosis. Dev Med Child Neurol. 2019 Nov;61(11):1289-1294. doi: 10.1111/dmcn.14233. Epub 2019 Apr 5.
PubMed 30950520Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
PubMed 6685237Centers for Disease Control. Healthy Weight. In. Vol 20162015
Disanto G, Barro C, Benkert P, Naegelin Y, Schadelin S, Giardiello A, Zecca C, Blennow K, Zetterberg H, Leppert D, Kappos L, Gobbi C, Kuhle J; Swiss Multiple Sclerosis Cohort Study Group. Serum Neurofilament light: A biomarker of neuronal damage in multiple sclerosis. Ann Neurol. 2017 Jun;81(6):857-870. doi: 10.1002/ana.24954.
PubMed 28512753Chitnis T, Gonzalez C, Healy BC, Saxena S, Rosso M, Barro C, Michalak Z, Paul A, Kivisakk P, Diaz-Cruz C, Sattarnezhad N, Pierre IV, Glanz BI, Tomic D, Kropshofer H, Haring D, Leppert D, Kappos L, Bakshi R, Weiner HL, Kuhle J. Neurofilament light chain serum levels correlate with 10-year MRI outcomes in multiple sclerosis. Ann Clin Transl Neurol. 2018 Oct 16;5(12):1478-1491. doi: 10.1002/acn3.638. eCollection 2018 Dec.
PubMed 30564615Barro C, Benkert P, Disanto G, Tsagkas C, Amann M, Naegelin Y, Leppert D, Gobbi C, Granziera C, Yaldizli O, Michalak Z, Wuerfel J, Kappos L, Parmar K, Kuhle J. Serum neurofilament as a predictor of disease worsening and brain and spinal cord atrophy in multiple sclerosis. Brain. 2018 Aug 1;141(8):2382-2391. doi: 10.1093/brain/awy154.
PubMed 29860296Siller N, Kuhle J, Muthuraman M, Barro C, Uphaus T, Groppa S, Kappos L, Zipp F, Bittner S. Serum neurofilament light chain is a biomarker of acute and chronic neuronal damage in early multiple sclerosis. Mult Scler. 2019 Apr;25(5):678-686. doi: 10.1177/1352458518765666. Epub 2018 Mar 15.
PubMed 29542376Kuhle J, Nourbakhsh B, Grant D, Morant S, Barro C, Yaldizli O, Pelletier D, Giovannoni G, Waubant E, Gnanapavan S. Serum neurofilament is associated with progression of brain atrophy and disability in early MS. Neurology. 2017 Feb 28;88(9):826-831. doi: 10.1212/WNL.0000000000003653. Epub 2017 Feb 1.
PubMed 28148632Valcarcel AM, Linn KA, Vandekar SN, Satterthwaite TD, Muschelli J, Calabresi PA, Pham DL, Martin ML, Shinohara RT. MIMoSA: An Automated Method for Intermodal Segmentation Analysis of Multiple Sclerosis Brain Lesions. J Neuroimaging. 2018 Jul;28(4):389-398. doi: 10.1111/jon.12506. Epub 2018 Mar 8.
PubMed 29516669Shinohara RT, Sweeney EM, Goldsmith J, Shiee N, Mateen FJ, Calabresi PA, Jarso S, Pham DL, Reich DS, Crainiceanu CM; Australian Imaging Biomarkers Lifestyle Flagship Study of Ageing; Alzheimer's Disease Neuroimaging Initiative. Statistical normalization techniques for magnetic resonance imaging. Neuroimage Clin. 2014 Aug 15;6:9-19. doi: 10.1016/j.nicl.2014.08.008. eCollection 2014.
PubMed 25379412Hagler DJ Jr, Hatton S, Cornejo MD, Makowski C, Fair DA, Dick AS, Sutherland MT, Casey BJ, Barch DM, Harms MP, Watts R, Bjork JM, Garavan HP, Hilmer L, Pung CJ, Sicat CS, Kuperman J, Bartsch H, Xue F, Heitzeg MM, Laird AR, Trinh TT, Gonzalez R, Tapert SF, Riedel MC, Squeglia LM, Hyde LW, Rosenberg MD, Earl EA, Howlett KD, Baker FC, Soules M, Diaz J, de Leon OR, Thompson WK, Neale MC, Herting M, Sowell ER, Alvarez RP, Hawes SW, Sanchez M, Bodurka J, Breslin FJ, Morris AS, Paulus MP, Simmons WK, Polimeni JR, van der Kouwe A, Nencka AS, Gray KM, Pierpaoli C, Matochik JA, Noronha A, Aklin WM, Conway K, Glantz M, Hoffman E, Little R, Lopez M, Pariyadath V, Weiss SR, Wolff-Hughes DL, DelCarmen-Wiggins R, Feldstein Ewing SW, Miranda-Dominguez O, Nagel BJ, Perrone AJ, Sturgeon DT, Goldstone A, Pfefferbaum A, Pohl KM, Prouty D, Uban K, Bookheimer SY, Dapretto M, Galvan A, Bagot K, Giedd J, Infante MA, Jacobus J, Patrick K, Shilling PD, Desikan R, Li Y, Sugrue L, Banich MT, Friedman N, Hewitt JK, Hopfer C, Sakai J, Tanabe J, Cottler LB, Nixon SJ, Chang L, Cloak C, Ernst T, Reeves G, Kennedy DN, Heeringa S, Peltier S, Schulenberg J, Sripada C, Zucker RA, Iacono WG, Luciana M, Calabro FJ, Clark DB, Lewis DA, Luna B, Schirda C, Brima T, Foxe JJ, Freedman EG, Mruzek DW, Mason MJ, Huber R, McGlade E, Prescot A, Renshaw PF, Yurgelun-Todd DA, Allgaier NA, Dumas JA, Ivanova M, Potter A, Florsheim P, Larson C, Lisdahl K, Charness ME, Fuemmeler B, Hettema JM, Maes HH, Steinberg J, Anokhin AP, Glaser P, Heath AC, Madden PA, Baskin-Sommers A, Constable RT, Grant SJ, Dowling GJ, Brown SA, Jernigan TL, Dale AM. Image processing and analysis methods for the Adolescent Brain Cognitive Development Study. Neuroimage. 2019 Nov 15;202:116091. doi: 10.1016/j.neuroimage.2019.116091. Epub 2019 Aug 12.
PubMed 31415884Kerbrat A, Aubert-Broche B, Fonov V, Narayanan S, Sled JG, Arnold DA, Banwell B, Collins DL. Reduced head and brain size for age and disproportionately smaller thalami in child-onset MS. Neurology. 2012 Jan 17;78(3):194-201. doi: 10.1212/WNL.0b013e318240799a. Epub 2012 Jan 4.
PubMed 22218275Brenton JN, Koshiya H, Engel CE, Herrod S, Engelhard M, Goldman MD. Utility of Physical Disability Outcome Measures in Pediatric-Onset Multiples Sclerosis. American Academy of Neurology. 2017.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT04593082
- Acronym / sponsor ID
- HSR200257
- Conditions
- Multiple Sclerosis
- Keywords
- Pediatric, Obesity, Neurodegeneration, Inflammation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 21 May 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Oct 2020 (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.
Obesity is one possible contributor to severity of multiple sclerosis and progression of the disease. We already know that obesity is a risk determinant for acquiring MS, yet the impact of obesity on pediatric MS disease expression and course is unknown. This study will evaluate the relationship between obesity, obesity-derived inflammatory mediators, and imaging metrics of MS severity in children. Understanding how childhood obesity contributes to MS severity/progression may yield fundamental insights into disease pathobiology - which may thereby lead to effective strategies for halting its progression in its earliest stages.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric MS Subjects | – | –Subjects with pediatric MS will undergo fasting lab work, non-contrasted MRI, DEXA scan, and surveys. |
| Healthy controls | – | –Non-MS pediatric control subjects who will undergo fasting lab work, DEXA scan, and surveys for comparison to control group. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will be draw from outpatient clinics at UVA and CHOP as well as the surrounding communities for each institution. Subjects will be screened for eligibility to include BMI measurements at time of study discussion if they are interested.
Key inclusion criteria (7 listed)
- Ability to provide informed consent (or assent for minors)
- Relapsing-remitting MS diagnosis per 2017 McDonald criteria
- Ages ≥ 10 years to ≤ 20 years
- Diagnosis of MS or first clinical symptom of MS (whichever comes first) within ≤ 36 months from the time of enrollment.
- Ability to provide informed consent (or assent for minors)
Key exclusion criteria (8 listed)
- Progressive form of MS
- Patients with an active, chronic disease of the immune system other than MS
- Conditions affecting the central nervous system (CNS) white matter (e.g. leukodystrophy) or for whom another condition may better explain imaging abnormalities (e.g. lupus)
- Myelin oligodendrocyte glycoprotein (MOG) antibodies on serologic testing
- Corticosteroid exposure within 30 days of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole brain volumes and focal demyelinating lesion volumes
Time frame: 3 years
58 patients with a recent MS diagnosis, stratified by weight category (29 normal weight and 29 overweight/obese). Subjects will undergo MRI to quantify total brain and lesion volume. Z-scores for volumetrics will be determined using age- and sex-matched normative data from the NIH-sponsored ABCD dataset. We will compare mean Z-scores of whole brain volume and focal demyelinating lesion volumes between the two groups.
2 secondary outcomes
Adipo-cytokine profiles
Time frame: 3 years
Adipo-cytokines correlation with brain volume loss and neuroaxonal injury
Time frame: 3 years
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 29 Apr 2026.
- Background: PubMed 25891547Brenton JN, Koenig S, Goldman MD. Vitamin D status and age of onset of demyelinating disease. Mult Scler Relat Disord. 2014 Nov;3(6):684-8. doi: 10.1016/j.msard.2014.07.004. Epub 2014 Jul 28.
- BackgroundWoolbright EB, Brenton JN. Attitudes toward obestity and diet modification in pediatric MS patients. Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS); February, 28 2020, 2019; West Palm Beach, FL.
- Background: PubMed 30950520Brenton JN, Woolbright E, Briscoe-Abath C, Qureshi A, Conaway M, Goldman MD. Body mass index trajectories in pediatric multiple sclerosis. Dev Med Child Neurol. 2019 Nov;61(11):1289-1294. doi: 10.1111/dmcn.14233. Epub 2019 Apr 5.
- Background: PubMed 6685237Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
- BackgroundCenters for Disease Control. Healthy Weight. In. Vol 20162015
- Background: PubMed 28512753Disanto G, Barro C, Benkert P, Naegelin Y, Schadelin S, Giardiello A, Zecca C, Blennow K, Zetterberg H, Leppert D, Kappos L, Gobbi C, Kuhle J; Swiss Multiple Sclerosis Cohort Study Group. Serum Neurofilament light: A biomarker of neuronal damage in multiple sclerosis. Ann Neurol. 2017 Jun;81(6):857-870. doi: 10.1002/ana.24954.
- Background: PubMed 30564615Chitnis T, Gonzalez C, Healy BC, Saxena S, Rosso M, Barro C, Michalak Z, Paul A, Kivisakk P, Diaz-Cruz C, Sattarnezhad N, Pierre IV, Glanz BI, Tomic D, Kropshofer H, Haring D, Leppert D, Kappos L, Bakshi R, Weiner HL, Kuhle J. Neurofilament light chain serum levels correlate with 10-year MRI outcomes in multiple sclerosis. Ann Clin Transl Neurol. 2018 Oct 16;5(12):1478-1491. doi: 10.1002/acn3.638. eCollection 2018 Dec.
- Background: PubMed 29860296Barro C, Benkert P, Disanto G, Tsagkas C, Amann M, Naegelin Y, Leppert D, Gobbi C, Granziera C, Yaldizli O, Michalak Z, Wuerfel J, Kappos L, Parmar K, Kuhle J. Serum neurofilament as a predictor of disease worsening and brain and spinal cord atrophy in multiple sclerosis. Brain. 2018 Aug 1;141(8):2382-2391. doi: 10.1093/brain/awy154.
- Background: PubMed 29542376Siller N, Kuhle J, Muthuraman M, Barro C, Uphaus T, Groppa S, Kappos L, Zipp F, Bittner S. Serum neurofilament light chain is a biomarker of acute and chronic neuronal damage in early multiple sclerosis. Mult Scler. 2019 Apr;25(5):678-686. doi: 10.1177/1352458518765666. Epub 2018 Mar 15.
- Background: PubMed 28148632Kuhle J, Nourbakhsh B, Grant D, Morant S, Barro C, Yaldizli O, Pelletier D, Giovannoni G, Waubant E, Gnanapavan S. Serum neurofilament is associated with progression of brain atrophy and disability in early MS. Neurology. 2017 Feb 28;88(9):826-831. doi: 10.1212/WNL.0000000000003653. Epub 2017 Feb 1.
- Background: PubMed 29516669Valcarcel AM, Linn KA, Vandekar SN, Satterthwaite TD, Muschelli J, Calabresi PA, Pham DL, Martin ML, Shinohara RT. MIMoSA: An Automated Method for Intermodal Segmentation Analysis of Multiple Sclerosis Brain Lesions. J Neuroimaging. 2018 Jul;28(4):389-398. doi: 10.1111/jon.12506. Epub 2018 Mar 8.
- Background: PubMed 25379412Shinohara RT, Sweeney EM, Goldsmith J, Shiee N, Mateen FJ, Calabresi PA, Jarso S, Pham DL, Reich DS, Crainiceanu CM; Australian Imaging Biomarkers Lifestyle Flagship Study of Ageing; Alzheimer's Disease Neuroimaging Initiative. Statistical normalization techniques for magnetic resonance imaging. Neuroimage Clin. 2014 Aug 15;6:9-19. doi: 10.1016/j.nicl.2014.08.008. eCollection 2014.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
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.
J Nicholas Brenton, MD principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Virginia at 2 sites 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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?
Whole brain volumes and focal demyelinating lesion volumes (time frame: 3 years). 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 NCT04593082, which also lists 20 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 29 Apr 2026.