CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Pregnenolone +1 moredrug
Likely dose
Pregnenolone 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01956279
NCT01956279Phase 2Completed
CompareCT.gov

Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)

VA Office of Research and Development·interventional·Posted Oct 8, 2013·Updated May 1, 2020

In Brief

A Phase 2 clinical trial evaluating Pregnenolone and Placebo for Fatigue and 2 related conditions. Completed, enrolled 170 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue, Musculoskeletal Pain, Cognitive Decline
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 10, 2018
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.7 years ago

Interventions

Pregnenolonedrug

Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days

Placebodrug

Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days