Clinical Trial: ReCOVER – Clemastine Fumarate in Optic Neuritis

Funding:

Private sponsor

Description

WE ARE ACTIVELY RECRUITING PEOPLE EXPERIENCING A SUSPECTED OR DIAGNOSED ACUTE OPTIC NEURITIS IN A PREVIOUSLY UNAFFECTED EYE. VISUAL SYMPTOMS MUST BE WITHIN THE PAST 3 WEEKS AND THE PATIENT MUST BE STEROID NAIVE. 

ReCOVER aims to assess the effect of Clemastine Fumarate as a myelin repair agent and its potential for neuroprotection in people with acute demyelinating optic neuritis. The study will also evaluate the tolerability of Clemastine Fumarate, originally approved as a first-generation antihistamine, in people with acute myelin-damaging optic neuritis. Study procedures will include assessments for evidence of myelin repair in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. The study will also assess the robustness and stability of this clinical effect in patients taking Clemastine Fumarate for up to 9 months total (3 months on treatment). Participants in this study will receive standard-of-care anti-inflammatory steroids to treat the optic neuritis immediately after the completion of the joint screening/baseline visit. However, participants cannot participate in any other investigational new drug research study concurrently but may remain on any current disease-modifying treatment for MS.