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NCT01956279 · ClinicalTrials.gov registry record · Phase 2
Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
NCT01956279: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT01956279 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 170 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01956279, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
Study Summary
This study will investigate the use of adjunctive pregnenolone for the following: 1. fatigue that has limited usual activity, 2. musculoskeletal pain involving 2 or more regions of the body and, 3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report) in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.
Primary Outcome
These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, an
Interventions
- DRUG Placebo
- DRUG Pregnenolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2018-10-10 |
| Phase | Phase 2 |
What the finished NCT01956279 record still lists
NCT01956279 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01956279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01956279 about?
NCT01956279 is a clinical study titled "Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)". This study will investigate the use of adjunctive pregnenolone for the following: 1. fatigue that has limited usual activity, 2. musculoskeletal pain involving 2 or more regions of the body and, 3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report) in Veterans de...
What is the current status of trial NCT01956279?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2013-10-01. Estimated completion is 2018-10-10.
What interventions are being tested in trial NCT01956279?
The interventions under investigation include: Placebo (DRUG), Pregnenolone (DRUG).
Who is sponsoring clinical trial NCT01956279?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01956279's enrollment target sits among peer trials
170 399th of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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