Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 55 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- "This clinical trial is intended to assess magnetic resonance imaging evidence of remyelination using Clemastine Fumarate in patients with acute demyelinated lesions."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether clemastine fumarate can protect and repair myelin, the covering around nerves, after recent damage from swelling in the brain. It uses several types of MRI scans, including a newer method, to look for changes. It is for adults ages 18–55 with relapsing-remitting multiple sclerosis (MS), which causes symptoms that come and go.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a consent form before any study tests.
- Have relapsing-remitting MS and have had the disease for less than 15 years.
- Be 18–55 years old.
- Women must use approved, highly effective birth control during the study, be unable to become pregnant, or have been past menopause for at least 1 year. Not having sex that could cause pregnancy is also allowed, but birth control is needed if this changes. Timing sex around fertile days is not allowed.
Who can't join
- MRI shows major brain shrinkage for your age, or the most recent MRI, taken within 3 months, shows a new area of damage. An MS disability score (EDSS) of 4.5 or higher also rules you out.
- Allergy to clemastine, related allergy medicines, or their ingredients; steroid treatment within 30 days before screening; another possible myelin repair treatment; or another study without approval.
- Past treatment with alemtuzumab, mitoxantrone, cyclophosphamide, radiation to lymph tissue, or vaccines targeting immune cells called T cells or their receptors.
- Past cancer or a serious problem with the heart's electrical signals; untreated low vitamin B12 or low thyroid activity; or another major illness or abnormal test result that the study doctor thinks could affect safety or results.
- Kidney blood test called creatinine above 1.5 mg/dL, or liver blood tests called AST, ALT, or alkaline phosphatase above twice the normal upper limit.
- Suicidal thoughts or actions within 6 months before the study starts, or drug or alcohol abuse within the past year.
- Pregnant, breastfeeding, or planning to become pregnant.
- Unable to have MRI scans, including because of severe fear of small spaces; or braces or metal in the jaw or face that cannot be removed.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
CA
- Sandler Neurosciences Building, Neurological Clinical Research Unit · San Francisco, CA 94107Harkeerat Halait, BS · Study contact · 415-745-1304 · Harkee.Halait@ucsf.eduAri J Green, MD · Principal investigatorMore trials in San Francisco