ReCOVER V1.2 Jan 2016
Research type
Research Study
Full title
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
IRAS ID
203282
Contact name
Misha Ladva
Contact email
Sponsor organisation
University of California, San Francisco
Eudract number
2018-001756-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This study will be examining possible remyelinating effects of clemastine fumarate on patients experiencing acute optic neuritis. No reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at UCSF. Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first RCT documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.
This study seeks to follow-up on that and examine clemastine fumarate's protective and reparative effects in the context of acute optic neuritis.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0047
Date of REC Opinion
26 Mar 2019
REC opinion
Further Information Favourable Opinion