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Antihistamine

Clemastine for Optic Neuritis (ReCOVER Trial)

Phase 2
Recruiting
Led By Ari Green, MD, MCR
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be between 18 and 65 years old
Must not have
Simultaneous bilateral optic neuritis
History of significant cardiac conduction block
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 1 month, 3 months, 9 months

Summary

This trial is testing if the antihistamine drug clemastine can help repair nerve damage in people with optic neuritis, and if it is well tolerated.

Who is the study for?
This trial is for individuals recently diagnosed or suspected to have acute optic neuritis in one eye, who understand and consent to the study. They can be on standard disease-modifying treatments but must use contraception if applicable. Exclusions include major eye diseases, significant health conditions like heart block or cancer, pregnancy, other concurrent studies without approval, and certain lab abnormalities.
What is being tested?
The ReCOVER trial is testing clemastine fumarate's ability to repair nerve insulation (remyelination) in patients with acute optic neuritis versus a placebo. The study will monitor remyelination through visual tests and MRI while allowing participants to continue their usual disease-modifying therapies.
What are the potential side effects?
Clemastine may cause drowsiness, dry mouth, blurred vision, constipation and difficulty urinating due to its antihistamine properties. Since it's an older medication initially used for allergies, these side effects are generally well-known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have or might have optic neuritis in one eye, diagnosed within the last 3 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have inflammation in both of my optic nerves at the same time.
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I have a history of serious heart rhythm problems.
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I have had cancer in the past.
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I have not treated my B12 deficiency or hypothyroidism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 1 month, 3 months, 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 1 month, 3 months, 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in P100 latency on full-field visual evoked potential
Change in low contrast visual acuity
Secondary study objectives
Change in retinal nerve fiber layer thickness on optical coherence tomography
Expanded Disability Status Scale score
Radiological outcomes assessed by magnetic resonance imaging

Side effects data

From 2016 Phase 2 trial • 50 Patients • NCT02040298
20%
Increased trigylcerides
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clemastine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ClemastineExperimental Treatment1 Intervention
Participants will receive clemastine until 3 months and then will be off treatment until 9 month time point.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo until 3 months and then will be off treatment until 9 month time point.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clemastine
2007
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,860 Total Patients Enrolled
Moorfields Eye Hospital NHS Foundation TrustOTHER
68 Previous Clinical Trials
289,388 Total Patients Enrolled
Ari Green, MD, MCRPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Clemastine Fumarate (Antihistamine) Clinical Trial Eligibility Overview. Trial Name: NCT02521311 — Phase 2
Optic Neuritis Clinical Trial 2023: Clemastine Fumarate Highlights & Side Effects. Trial Name: NCT02521311 — Phase 2
~15 spots leftby Aug 2026
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