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
Sponsor:
Brief Summary:
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.
Criteria
– Patients diagnosed or suspected to have an acute demyelinating optic neuritis in at
least one eye within 2 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 period of trial (women)
– Understand and signed informed consent
Exclusion Criteria:
– Other major ophthalmologic disease / concomitant ophthalmologic disorders (e.g.
diabetes, macular degeneration, glaucoma, severe myopia, etc)
– Disc hemorrhages in qualifying eye
– No light perception in qualifying eye
– Simultaneous bilateral optic neuritis
– Cotton wool spots in qualifying eye
– Macular star in qualifying eye
– History of significant cardiac conduction block
– History of cancer
– Suicidal ideation or behavior in 6 months prior to baseline
– Pregnancy, breastfeeding, or planning to become pregnant
– Involved with other study protocol simultaneously without prior approval
– Concomitant use of any other putative remyelinating therapy as determined by
investigator
– Serum creatinine > 1.5 mg/dL; aspartate transaminase (AST), alanine transaminase
(ALT), or alkaline phosphatase > 2 times the upper limit of normal
– History of drug or alcohol abuse within the past year
– Untreated B12 deficiency (as determined by B12 serological assessments and metabolites
including methylmalonic acid (MMA) and homocysteine) or untreated hypothyroidism
– Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic,
urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic,
renal, or other major diseases that, in the PI’s judgment, may affect interpretation
of study results or patient safety
– History or presence of clinically significant medical illness or laboratory
abnormality that, in the opinion of the investigator would preclude participation in
the study.
Locations
- University of California San Francisco, San Francisco, California, United States, 94158
