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NCT01233609 · ClinicalTrials.gov registry record · Phase 2
Trial of Oral Valproic Acid for Retinitis Pigmentosa
A Phase 2 study of Retinitis Pigmentosa, sponsored by Foundation Fighting Blindness.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 6
- Study locations
NCT01233609: Completed Phase 2 study of Retinitis Pigmentosa, sponsored by Foundation Fighting Blindness.
NCT01233609 is a Phase 2 study of Retinitis Pigmentosa that has completed, run by Foundation Fighting Blindness. The registered enrollment target is 90 participants, below the 259-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (65% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01233609, a Phase 2 study of Retinitis Pigmentosa, has completed, sponsored by Foundation Fighting Blindness.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 6
- Study locations
Study Summary
The objectives of this study are to evaluate the efficacy of Valproic Acid (VPA) to both slow the progression of visual function loss and/or to restore visual function in patients with Autosomal Dominant Retinitis Pigmentosa (RP) and to collect safety and tolerability information.
Primary Outcome
Mean change in visual field area from baseline to 52 weeks. Visual field area is measured with semi-automated kinetic perimetry (SKP) using the Octopus 900 (Haag-Streit) with the III4e target size for each eye and done at least twice to ensure reliable sessions; the visual field area measurements are averaged over the two sessions. Analysis performed with linear mixed model
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Valproic Acid
Study Locations (6)
Florida
- University of Miami, Bascom Palmer Eye Institute - Miami
Michigan
- University of Michigan, Ann Arbor - Ann Arbor
Oregon
- Oregon Health & Science University - Portland
Tennessee
- University of Tennessee, Hamilton Eye Institute - Memphis
Texas
- Retina Foundation of the Southwest - Dallas
Utah
- University of Utah School of Medicine, Moran Eye Center - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01233609 record still lists
NCT01233609 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 259-participant average among 37 other Retinitis Pigmentosa trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Retinitis Pigmentosa appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01233609 lists 6 locations in 6 states (Florida, Michigan, Oregon).
Frequently Asked Questions
What is clinical trial NCT01233609 about?
NCT01233609 is a clinical study titled "Trial of Oral Valproic Acid for Retinitis Pigmentosa". The objectives of this study are to evaluate the efficacy of Valproic Acid (VPA) to both slow the progression of visual function loss and/or to restore visual function in patients with Autosomal Dominant Retinitis Pigmentosa (RP) and to collect safety and tolerability information.
What is the current status of trial NCT01233609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2010-11. Estimated completion is 2015-12.
What conditions does trial NCT01233609 study?
This clinical trial studies the following conditions: Retinitis Pigmentosa.
What interventions are being tested in trial NCT01233609?
The interventions under investigation include: Placebo (DRUG), Valproic Acid (DRUG).
Who is sponsoring clinical trial NCT01233609?
This trial is sponsored by Foundation Fighting Blindness, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01233609 being conducted?
This trial has 6 study locations across Florida, Michigan, Oregon, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01233609's enrollment target sits among peer trials
90 13th of 37 higher than 25 of 37 other Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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