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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of California, San Francisco

About this trial

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 criteria

Qualifiers

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

Use of disease-modifying therapies is not a contraindication

Use of appropriate contraception during the period of trial (women)

Understand and sign the informed consent

Disqualifiers

Other major ophthalmologic diseases / concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, glaucoma, severe myopia, etc)

Disc hemorrhages in the qualifying eye

No light perception in qualifying eye

Simultaneous bilateral optic neuritis

Trial design

Treatments tested in this trial

  • Clemastine
  • Placebo

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborator