A Randomized, Double-Blind, Placebo Controlled Trial to Assess Clemastine Fumarate for Remyelination in Acute Optic Neuritis

What this Trial Is About

Researchers are evaluating clemastine fumarate as a potential remyelinating agent in adults with acute optic neuritis, an inflammatory disease that affects the optic nerve causing vision loss or blurred vision. This phase 2 randomized, double-blind, placebo-controlled trial aims to assess both the clinical evidence of remyelination and the tolerability of clemastine, originally an antihistamine medication. The study also uses advanced imaging and electrophysiologic techniques to detect remyelination in the visual pathways and brain, addressing a significant unmet need in treatments for demyelinating diseases like multiple sclerosis. Participants will be randomly assigned to receive either clemastine or a placebo. Clemastine dosing starts with 12 mg daily (4 mg three times a day) for 7 days, then continues with 8 mg daily (4 mg twice a day) up to 3 months. After this treatment period, participants stop the study drug and are monitored until 9 months. Both groups undergo this same schedule, with no treatment from 3 to 9 months, followed by reevaluation. Patients can continue any standard disease-modifying therapies during the study if they are already on them. During the study, participants will have assessments at baseline, 1 week, 1 month, 3 months, and 9 months, which include visual evoked potentials, low contrast visual acuity tests, retinal nerve fiber layer thickness via optical coherence tomography, MRI scans, and disability scoring. Researchers will monitor for adverse events, treatment tolerability, and changes indicating remyelination. The total study duration for each participant is up to 9 months, with ongoing safety and efficacy evaluations throughout this period.

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