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
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborator