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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 1 month, 3 months, 9 months
Awards & highlights

ReCOVER Trial 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.Check my eligibility
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.See study design
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.

ReCOVER Trial Eligibility Criteria

Inclusion Criteria

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

ReCOVER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in P100 latency on full-field visual evoked potential
Change in low contrast visual acuity
Secondary outcome measures
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

ReCOVER 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
2,506 Previous Clinical Trials
15,238,465 Total Patients Enrolled
Moorfields Eye Hospital NHS Foundation TrustOTHER
66 Previous Clinical Trials
289,655 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study include middle-aged individuals as participants?

"The age limit for this trial is 55 years old. All participants must be of legal age in their region (18+)."

Answered by AI

Has Clemastine been sanctioned by the FDA?

"Clemastine received a safety score of 2 because, although there is some data supporting its safety, none of it suggests that the medication is effective."

Answered by AI

Are there still unfilled positions for participants in this research project?

"Yes, this clinical trial is recruiting patients as of September 6th, 2022. The original posting was on February 28th, 2017."

Answered by AI

How can I qualify to participate in this research?

"Eligible participants for this study must be between 18-55 years old, have optic neuritis in one eye (or suspected to have it), and cannot be using any disease-modifying therapies. If you meet these requirements and can understand and sign the informed consent, then you are encouraged to apply."

Answered by AI

What does this clinical trial hope to achieve?

"The main goal of this study, which will be evaluated over the course of 9 months through check-ins at baseline and 1 week, 1 month, 3 months, and 9 months, is to asses Change in P100 latency on full-field visual evoked potential. Additionally, this trial will also look at Radiological outcomes assessed by magnetic resonance imaging defined as To evaluate the efficacy of clemastine relative to placebo in increasing magnetization transfer ratios and myelin water fraction derived from magnetic resonance imaging of the brain during the period of exposure to active treatment. Measures will be reported as change between baseline and 9 months., Change in retinal nerve"

Answered by AI

Clemastine is most often used to treat what condition?

"Clemastine can help ameliorate the symptoms of urticaria, allergic rhinitis (disorder), and catarrh."

Answered by AI

How many individuals are being given the opportunity to participate in this research project?

"That is correct. The clinical trial was originally posted on 2/28/2017 and was most recently updated on 9/6/2022. The study is currently seeking 90 patients from 1 location."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
What state do they live in?
New York
What site did they apply to?
University of California San Francisco

Why did patients apply to this trial?

My girlfriend searched for and told me about it.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

What is involved in the trial?
PatientReceived 1 prior treatment
Recent research and studies
Nature MedicineJournal
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Mei, Feng, Stephen P J Fancy, Yun-An A Shen, Jianqin Niu, Chao Zhao, Bryan Presley, Edna Miao, et al.. 2014. “Micropillar Arrays as a High-throughput Screening Platform for Therapeutics in Multiple Sclerosis”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm.3618.
clinicaltrials.govStudy
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
2017. "Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02521311.
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