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New treatment option for Optic Neuritis
Official title Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
ClinicalTrials.gov ID: NCT02521311
What this study is testing
What is Clemastine?
Clemastine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for optic neuritis.
Also referred to as Tavist, Clemastine fumarate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.