ClinicalTrials.gov record NCT06065670

Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 55 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a randomized, double-blind, placebo-controlled crossover trial testing clemastine fumarate as a possible remyelinating treatment in people with acute inflammatory demyelinating brain lesions (for example, some people with relapsing-remitting multiple sclerosis). The study uses multi-parametric MRI, including a new Ultrashort Echo Time (UTE) MRI technique, to measure myelin-related changes. Participants receive clemastine and placebo in different periods and have MRI and clinical assessments at baseline, 3 months, and 6 months.

What it is studying. Whether clemastine fumarate changes MRI measures thought to reflect myelin (myelin water fraction, T1 relaxation time, UTE fraction) in the corpus callosum and other brain regions of people with acute inflammatory demyelinating lesions, and to assess tolerability in this population.

What the researchers hope to learn. To measure MRI evidence of remyelination after clemastine treatment, to evaluate the Ultrashort Echo Time (UTE) MRI technique for detecting myelin changes, to identify optimal MRI sequences and brain locations for future remyelinating trials, and to assess tolerability and clinical outcomes (including fatigue) during treatment.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with acute inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of acute demyelinating lesions. 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 acute 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 lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination. 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 acute lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination and compare it to the other assessments.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Clemastine Fumarate
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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.
  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Treatments capable of remyelination are a major unmet need for demyelinating diseases that involve myelin damage, loss, or dysfunction in the central nervous system (CNS). Acute 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 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 acute 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 acute lesions, 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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized and blinded in a crossover design: they will take study tablets (clemastine or matched placebo) in 90‑day periods — active periods use 12 mg daily for 14 days then 8 mg daily for the remaining 76 days — and then switch to the other study treatment. They will undergo multi‑parametric brain MRI scans (including Ultrashort Echo Time sequences) at baseline, about 3 months, and about 6 months to measure myelin-related imaging outcomes. They will complete questionnaires (including the Fatigue Scale for Motor and Cognitive Functions), have screening and safety blood tests to check kidney/liver function and B12/thyroid status, and be monitored for adverse events and tolerability throughout the study. MRI compatibility is required (no disallowed metal in jaw/face and no extreme claustrophobia). If you already take a standard disease-modifying treatment, the registry says you may stay on it during the study.

How the study is structured. Interventional drug trial. Participants are randomly assigned to one of two groups in a quadruple-blind crossover design: one group takes clemastine for the first 90 days then placebo the next 90 days; the other group starts with placebo then switches to clemastine (clemastine dosing: 12 mg for 14 days, then 8 mg). MRI and clinical assessments occur at baseline, about 3 months, and about 6 months. The trial compares MRI changes and tolerability between clemastine and placebo periods within the same participants.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Demyelinating Diseases; Demyelination; Corpus Callosum; Multiple Sclerosis Brain Lesion; Multiple Sclerosis Acute and Progressive; Clinically Isolated Syndrome, CNS Demyelinating. Does it apply to my diagnosis?
  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Sep 15, 2026 (estimated)
Primary completion
Oct 30, 2028 (estimated)
Study completion
Oct 30, 2028 (estimated)
Target enrollment
44 participants (estimated)
Last updated on registry
Mar 11, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of California, San Francisco

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Sandler Neurosciences Building, Neurological Clinical Research Unit

    San Francisco, California, 94107 · United States

Terms used on this page · explanations by MedicalUpdates.ai

MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
endpoint
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
secondary endpoint
An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.
follow up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
Prior treatment
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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