Can a common antihistamine help heal the optic nerve?
NCT ID NCT02521311
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether clemastine fumarate, a drug originally approved for allergies, can help repair nerve damage in people with acute optic neuritis (inflammation of the optic nerve). About 90 participants will receive either clemastine or a placebo for 9 months. Researchers will measure nerve repair using vision tests and brain scans. Participants can continue their usual disease-modifying treatments during the study.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2017
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients diagnosed or suspected to have an acute demyelinating optic neuritis in at least one eye within 3 weeks from the onset of any visual symptom other than pain * Use of disease-modifying therapies is not a contraindication * Use of appropriate contraception during the period of trial (women) * Understand and sign the informed consent Exclusion Criteria: * Other major ophthalmologic diseases / concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, glaucoma, severe myopia, etc) * Disc hemorrhages in the qualifying eye * No light perception in qualifying eye * Simultaneous bilateral optic neuritis * Cotton wool spots in the qualifying eye * Macular star in the qualifying eye * 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 * Serum creatinine \> 1.5 mg/dL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \> 2 times the upper limit of normal * 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 or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study. * Positive for NMO antibody discovered within the first 2 weeks after randomization.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of California San Francisco
RECRUITINGSan Francisco, California, 94158, United States
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Other studies related to the condition(s) this trial covers.
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