Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
Recruiting
Phase 2Interventional Study
Optic Neuritis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
University of California, San Francisco · Other
Who this trial is looking for
This trial is looking for people with a recent diagnosis of optic neuritis. Participants will take clemastine and undergo tests to measure its effects on their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with acute optic neuritis in one eye within the last 3 weeks.
I can use birth control during the trial if I am female.
I understand what this trial involves and can sign the consent form.
You may not be able to join if
I have other major eye diseases like diabetes or glaucoma.
I have no light perception in the affected eye.
I have had significant heart issues or a history of cancer.
I have had suicidal thoughts or behavior in the last 6 months.
I am pregnant, breastfeeding, or planning to become pregnant.
I am involved in another research study without approval.
I have a drug or alcohol abuse history in the past year.
I have untreated deficiencies that could affect my health.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 electro…
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.
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Eligibility 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 pe…
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.
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