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

NCT02521311 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 15-17428
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

multiple sclerosis; eye pain; vision loss

Outcome Measures

Primary Outcomes (2)

• Change in P100 latency on full-field visual evoked potential

  To evaluate the efficacy of clemastine relative to placebo for reducing P100 latencies on full field transient pattern reversal visual evoked potentials. Measure will be reported as difference in P100 latency from baseline to 9 months.

  baseline, 1 week, 1 month, 3 months, 9 months

• Change in low contrast visual acuity

  The second primary outcome is to measure the effectiveness of clemastine relative to placebo at improving patient performance on ETDRS low contrast visual acuity chart testing (2.5% black on white) during the recovery from an acute optic neuritis. Measure will be reported as difference in ETDRS score from baseline to 9 months.

  baseline, 1 week, 1 month, 3 months, 9 months

Secondary Outcomes (3)

• Change in retinal nerve fiber layer thickness on optical coherence tomography

  baseline, 1 week, 1 month, 3 months, 9 months

• Radiological outcomes assessed by magnetic resonance imaging

  baseline, 9 month

• Expanded Disability Status Scale score

  baseline, 9 months

Study Arms (2)

Clemastine

EXPERIMENTAL

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

Drug: Clemastine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Clemastine DRUG

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.

Also known as: Tavist, Clemastine fumarate, Walhist

Clemastine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: collaborator
• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (1)

• Mei F, Fancy SPJ, Shen YA, Niu J, Zhao C, Presley B, Miao E, Lee S, Mayoral SR, Redmond SA, Etxeberria A, Xiao L, Franklin RJM, Green A, Hauser SL, Chan JR. Micropillar arrays as a high-throughput screening platform for therapeutics in multiple sclerosis. Nat Med. 2014 Aug;20(8):954-960. doi: 10.1038/nm.3618. Epub 2014 Jul 6.

  PMID: 24997607 BACKGROUND

MeSH Terms

Conditions

Optic Neuritis; Multiple Sclerosis; Eye Pain; Vision Disorders

Interventions

Clemastine

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Eye Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Sensation Disorders

Intervention Hierarchy (Ancestors)

Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ari Green, MD, MCR

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harkeerat Halait

CONTACT

415.353.2707; Harkeerat.Halait@ucsf.edu

Angelica Montevirgen, BS

CONTACT

415.745.1304; Angelica.Montevirgen@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: February 28, 2017
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)