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NCT02521311 · ClinicalTrials.gov registry record · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
A Phase 2 study of Optic Neuritis, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT02521311: Recruiting Phase 2 study of Optic Neuritis, sponsored by University of California, San Francisco.
NCT02521311 is a Phase 2 study of Optic Neuritis that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 90 participants, below the 787-participant average among 5 other Optic Neuritis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02521311, a Phase 2 study of Optic Neuritis, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Clemastine
Study Locations (1)
California
- University of California San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2017-02-28 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What NCT02521311 shows while recruiting
NCT02521311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 787-participant average among 5 other Optic Neuritis trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Optic Neuritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02521311 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02521311 about?
NCT02521311 is a clinical study titled "Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)". 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 ass...
What is the current status of trial NCT02521311?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2017-02-28. Estimated completion is 2028-08.
What conditions does trial NCT02521311 study?
This clinical trial studies the following conditions: Optic Neuritis.
What interventions are being tested in trial NCT02521311?
The interventions under investigation include: Placebo (DRUG), Clemastine (DRUG).
Who is sponsoring clinical trial NCT02521311?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02521311 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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