Allergy pill shows promise for MS repair in small trial
NCT ID NCT05359653
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether clemastine fumarate, a common allergy medicine, can help repair the protective coating around nerves (myelin) in people with multiple sclerosis. About 74 adults with relapsing-remitting MS will receive either the drug or a placebo, and advanced MRI scans will measure changes in myelin over six months. The goal is to see if this cheap, safe drug can become a first-ever repair therapy for MS.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clemastine fumarate (an over-the-counter allergy medicine)
- What this could lead to
- If it works, this could point toward a treatment that repairs damaged nerve insulation in multiple sclerosis, potentially slowing or reversing some disability.
- What could go wrong
- This is an early-phase trial with only 74 participants, so results may not apply to all MS patients. The drug is being tested for a new use, and it may not show clear benefit on MRI scans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2023
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple sclerosis (MS) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Sandler Neurosciences Building, Neurological Clinical Research Unit
RECRUITINGSan Francisco, California, 94107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can diet ease the crushing fatigue of multiple sclerosis?
- Which MS treatment strategy preserves the brain better?
- Can a gentle electric zap to the brain restore memory in MS?
- Brain scans may reveal how MS drug affects mental fatigue
- Brain scans could reveal which MS drugs fight mental exhaustion
- Brain shrinkage as a crystal ball for MS progression?