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Clemastine Fumarate for Acute Optic Neuritis (ReCOVER)

This study is testing clemastine fumarate, a drug originally used for allergies, to see if it can help repair the protective covering (myelin) around nerves in people with acute optic neuritis. Optic neuritis is a condition where the nerve connecting your eye to your brain becomes inflamed, often causing vision problems. Researchers want to know if clemastine fumarate can improve vision and if it's well-tolerated. You might be able to join if you are between 18 and 55 years old and have been recently diagnosed with optic neuritis in at least one eye. The study will measure changes in your vision and how quickly your optic nerve responds to light to see if the treatment is successful. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 90 participants. Participants will receive either clemastine or a placebo (an inactive substance) for three months.
What's involved
You would take clemastine or placebo daily for three months, then be off treatment for six months. You will have vision and nerve response tests at baseline, 1 week, 1 month, 3 months, and 9 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be reevaluated at 9 months, which is six months after stopping treatment.

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NCT02521311

Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)

Recruiting
PHASE2Ages 18–55InterventionalTreatment
University of California, San Francisco
~90 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:ClemastinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in P100 latency on full-field visual evoked potential
Measured over baseline, 1 week, 1 month, 3 months, 9 months
+1 more outcome measured

Conditions

Optic Neuritis

Explore related trials

Multiple SclerosisOptic Neuritis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ari Green, MD, MCR · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Harkeerat Halait
[email protected]
415.353.2707
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in P100 latency on full-field visual evoked potentialbaseline, 1 week, 1 month, 3 months, 9 months

    To evaluate the efficacy of clemastine relative to placebo for reducing P100 latencies on full field transient pattern reversal visual evoked potentials. Measure will be reported as difference in P100 latency from baseline to 9 months.

  • Change in low contrast visual acuitybaseline, 1 week, 1 month, 3 months, 9 months

    The second primary outcome is to measure the effectiveness of clemastine relative to placebo at improving patient performance on ETDRS low contrast visual acuity chart testing (2.5% black on white) during the recovery from an acute optic neuritis. Measure will be reported as difference in ETDRS score from baseline to 9 months.