Using clemastine to promote healing in optic neuritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Privosegtor for optic neuritis: a late-phase test with standard care

  This trial tests whether privosegtor, added to the usual methylprednisolone treatment, helps people experiencing a first episode of optic neuritis.

  Recruiting at 4 sites Phase 3 Oculis · Livonia, Michigan and 3 other locations · NCT07623668

• Testing the 2022 Optic Neuritis Criteria in suspected cases of optic neuritis

  We’re trying to see if the 2022 criteria can correctly identify optic neuritis in patients with new or recent vision problems, including people with certain antibody types.

  Recruiting at 9 sites First Affiliated Hospital of Guangxi Medical University · Nanning, Guangxi and 8 other locations · NCT07623252

• Early versus rescue plasma exchange for severe optic neuritis and transverse myelitis

  This trial will see if starting plasma exchange early versus using it only as a rescue after high-dose steroids improves vision for adults with severe optic neuritis and improves neurologic recovery for adults with severe transverse myelitis.

  Recruiting at 32 sites Phase 3 Mayo Clinic · Birmingham, Alabama and 34 other locations · NCT07100990

• Efgartigimod to speed vision recovery in acute optic neuritis

  This pilot will test whether efgartigimod given with standard steroids helps adults having their first episode of optic neuritis regain vision faster and more fully than placebo.

  Recruiting at 2 sites Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT06453694

• Using light stimulation to enhance vision after optic neuritis in multiple sclerosis patients

  This study is testing if light stimulation can help improve vision in people with multiple sclerosis who have had optic neuritis.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT06389968

• Using edaravone to treat optic neuritis

  This study is testing if edaravone can help improve vision in Chinese adults who have recently experienced optic neuritis and have a specific antibody in their system.

  Recruiting First Affiliated Hospital of Guangxi Medical University · Nanning · NCT05540262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.