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Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)

NCT01956279 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2020-05-01

Study results available
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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.

Conditions

Interventions

DRUG

Pregnenolone

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

DRUG

Placebo

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Christine E. Marx, MD MA · Durham VA Medical Center, Durham, NC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-01
Primary Completion
2018-10-10
Completion
2018-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01956279 on ClinicalTrials.gov