Using clemastine to promote healing in optic neuritis
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
This study is testing if clemastine, an antihistamine, can help people with optic neuritis heal better by promoting the repair of damaged nerves in their eyes and brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT02521311 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of clemastine fumarate, a first-generation antihistamine, as a remyelinating agent in patients experiencing acute optic neuritis. Participants will undergo assessments to determine the drug's tolerability and its potential to promote remyelination in the visual pathway and brain, utilizing advanced imaging techniques and electrophysiological evaluations. Patients may continue their standard disease-modifying treatments during the study, but cannot participate in other investigational drug studies concurrently.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with acute demyelinating optic neuritis within three weeks of symptom onset, who are also on disease-modifying therapies.
Not a fit: Patients with other significant ophthalmologic diseases or conditions affecting the optic nerve may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from optic neuritis and potentially enhance recovery of vision.
How similar studies have performed: While the approach of using clemastine for remyelination is novel, previous studies have explored remyelination in similar contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Cotton wool spots in the qualifying eye * Macular star in the 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 protocols simultaneously without prior approval * Concomitant use of any other putative remyelinating therapy as determined by the 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 the 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. * Positive for NMO antibody discovered within the first 2 weeks after randomization.
Where this trial is running
San Francisco, California
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Ari Green, MD, MCR — University of California, San Francisco
- Study coordinator: Harkeerat Halait
- Email: Harkeerat.Halait@ucsf.edu
- Phone: 415.353.2707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.