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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT02521311
Phase
PHASE2
Status
Recruiting
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Conditions

  • Optic Neuritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 28, 2017
Status verified
Mar 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158
Harkeerat Halait
[email protected]
415-353-2707
Angelica Montevirgen, BS
[email protected]
415.745.1304

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