Actively Recruiting
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
Led by University of California, San Francisco · Updated on 2026-03-11
90
Participants Needed
1
Research Sites
596 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
M
Moorfields Eye Hospital NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this study is to assess clemastine as a remyelinating agent in patients with acute optic neuritis.The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with optic neuritis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. If they are on one, patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.
CONDITIONS
Official Title
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed or suspected to have acute demyelinating optic neuritis in at least one eye within 3 weeks from onset of visual symptoms other than pain
- Use of disease-modifying therapies allowed
- Women must use appropriate contraception during the trial
- Ability to understand and sign informed consent
You will not qualify if you...
- Other major eye diseases such as diabetes, macular degeneration, glaucoma, or severe myopia
- Disc hemorrhages or cotton wool spots in the qualifying eye
- No light perception in the qualifying eye
- Simultaneous optic neuritis in both eyes
- Macular star in the qualifying eye
- History of significant cardiac conduction block or cancer
- Suicidal ideation or behavior within 6 months before baseline
- Pregnancy, breastfeeding, or planning pregnancy
- Participation in other study protocols without approval
- Use of other remyelinating therapies
- Elevated serum creatinine or liver enzymes beyond specified limits
- History of drug or alcohol abuse within past year
- Untreated B12 deficiency or untreated hypothyroidism
- Significant medical illnesses affecting safety or study results
- Positive for NMO antibody within 2 weeks after randomization
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
H
Harkeerat Halait
CONTACT
A
Angelica Montevirgen, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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