Recruiting
Phase 2

Clemastine Fumarate

Sponsor:

UCLA

Code:

NCT02521311

Conditions

Optic Neuritis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Clemastine

Placebo

Study Details

Brief summary:

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.

Conditions

Optic Neuritis

Study ID

NCT02521311

Start date

Feb 28, 2017

Status verified date

Mar, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clemastine

Participants will receive clemastine until 3 months and then will be off treatment until 9 month time point.

placebo comparator: Placebo

Participants will receive placebo until 3 months and then will be off treatment until 9 month time point.

Interventions

Clemastine

12mg (4mg 3x/day) clemastine for 7 days followed by 8mg clemastine (4mg 2x/day) until 3 months. Patients will be off treatment from 3-9 months and will be reevaluated at 9 months.

Placebo

Equivalent placebo. 12mg (4mg 3x/day) placebo for 7 days followed by 8mg placebo (4mg 2x/day) until 3 months. Patients will be off treatment from 3-9 months and will be reevaluated at 9 months.

Primary outcome measure

  • Change in P100 latency on full-field visual evoked potential [ Time Frame: baseline, 1 week, 1 month, 3 months, 9 months ]
  • Change in low contrast visual acuity [ Time Frame: baseline, 1 week, 1 month, 3 months, 9 months ]

Central Contacts and Locations

Central contacts

Harkeerat Halait

415.353.2707Harkeerat.Halait@ucsf.edu

Angelica Montevirgen, BS

415.745.1304Angelica.Montevirgen@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Harkeerat Halait

415-353-2707Harkeerat.Halait@ucsf.edu

Angelica Montevirgen, BS

415.745.1304Angelica.Montevirgen@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • multiple sclerosis
  • eye pain
  • vision loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-11.