RecruitingPhase 2NCT02521311

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

A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis


Sponsor

University of California, San Francisco

Enrollment

90 participants

Start Date

Feb 28, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a medication called clemastine fumarate — an old antihistamine — can help repair the protective covering of nerve fibers (called myelin) in people who have just had an episode of optic neuritis, which is inflammation of the eye's optic nerve often seen in early multiple sclerosis. **You may be eligible if...** - You have been diagnosed with or are suspected of having acute optic neuritis (sudden vision problems due to nerve inflammation) within the past 3 weeks - You are using appropriate contraception if you are a woman who could become pregnant - You are able to understand and sign the informed consent form **You may NOT be eligible if...** - You have other significant eye diseases (such as glaucoma, severe nearsightedness, or macular degeneration) - You have no light perception in the affected eye - You have inflammation in both eyes at the same time - You have a history of significant heart rhythm problems or cancer - You have had thoughts of suicide or self-harm in the past 6 months - You are pregnant, breastfeeding, or planning to become pregnant - You have a history of drug or alcohol abuse in the past year - Your kidney or liver function tests are significantly abnormal - You have untreated vitamin B12 deficiency or thyroid problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClemastine

12mg (4mg 3x/day) clemastine for 7 days followed by 8mg clemastine (4mg 2x/day) until 3 months. Patients will be off treatment from 3-9 months and will be reevaluated at 9 months.

DRUGPlacebo

Equivalent placebo. 12mg (4mg 3x/day) placebo for 7 days followed by 8mg placebo (4mg 2x/day) until 3 months. Patients will be off treatment from 3-9 months and will be reevaluated at 9 months.


Locations(1)

University of California San Francisco

San Francisco, California, United States

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NCT02521311


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