RightFit
RecruitingPhase 2

Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "It can also be associated with a swollen optic disc (Optic Neuritis Study Group 1991, Hutchinson, W.M. 1976) and optic nerve enhancement on MRI (Kupersmith 2002)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether clemastine, an allergy medicine, can help repair the protective coating around nerves. It is for people with recent optic neuritis, swelling and damage to the nerve that carries sight signals from the eye to the brain. The study also checks how well people tolerate the medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed or suspected optic neuritis that damages the nerve coating in at least one eye. Sight symptoms other than pain must have started within the past 3 weeks.
  • You may keep taking your usual medicine that helps slow your disease.
  • Women must use suitable birth control during the study.
  • Be able to understand and sign the study consent form.

Who can't join

  • Have another major eye condition, such as glaucoma, severe nearsightedness, or eye problems linked to diabetes; or have optic neuritis in both eyes at the same time.
  • Cannot see any light in the study eye, or have bleeding at its nerve head, white patches on its retina, or a star-shaped pattern of deposits in its center.
  • Have a history of a serious block in the heart's electrical signals or a history of cancer.
  • Have had suicidal thoughts or behavior in the past 6 months, or drug or alcohol abuse in the past year.
  • Are pregnant, breastfeeding, or planning pregnancy.
  • Are in another study without prior approval, are in another experimental drug study, or use another treatment the study doctor thinks may repair nerve coatings.
  • Have untreated low vitamin B12 or an underactive thyroid; creatinine above 1.5 mg/dL on a kidney blood test; or certain liver blood tests above twice the normal limit.
  • Have another serious illness or abnormal test result that the study doctor thinks could make participation unsafe or affect results; or test positive within 2 weeks after study group assignment for NMO antibodies, linked to a disease that can harm eye nerves and the spinal cord.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

CA