Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)

NCT01956279 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SPLD-013-12S
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the use of adjunctive pregnenolone for the following:

1. 1.fatigue that has limited usual activity,
2. 2.musculoskeletal pain involving 2 or more regions of the body and,
3. 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

Fatigue; Musculoskeletal Pain; Cognitive Decline

Keywords

Pregnenolone; Gulf War Veteran; Fatigue; Musculoskeletal Pain; Cognitive Decline; Placebo Control

Outcome Measures

Primary Outcomes (1)

• Physical Component of the SF-36

  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, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline.

  Baseline to week 4, and Baseline to week 8

Secondary Outcomes (4)

• Brief Pain Inventory (BPI)

  Baseline to week 4, and Baseline to week 8

• Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A)

  Baseline to week 4, and Baseline to week 8

• Multidimensional Fatigue Inventory (MFI)

  Baseline to week 4, and Baseline to week 8

• Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R)

  Baseline to week 4, and Baseline to week 8

Study Arms (2)

Pregnenolone (Arm 1)

EXPERIMENTAL

Pregnenolone

Drug: Pregnenolone

Placebo (Arm 2)

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Pregnenolone DRUG

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

Pregnenolone (Arm 1)

Placebo DRUG

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

Placebo (Arm 2)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.
• Veterans who report at least 2 of the following 3 symptoms that began in 1990 or thereafter, that lasted for more than 6 months, and that are present at the time of screening: 1) fatigue that limited usual activity, 2) musculoskeletal pain involving 2 or more regions of the body, 3) cognitive symptoms (memory, concentration, or attentional difficulties by self-report)
• Stable on medication regimen (no change in last 4 weeks) and no anticipated change in medication during study.
• Able to provide informed consent for study participation.

You may not qualify if:

• Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g. unstable angina, seizures, cerebrovascular accident, decompensated congestive heart failure, central nervous system (CNS) infection, cancer \[other than non-melanoma skin cancer\], or history of HIV seropositivity), which would pose a risk to the patient if s/he were to participate in the study or that might confound the results of the study.
• Concurrent enrollment in another clinical trial.
• Pregnant women or women of child-bearing potential who are not surgically-sterile or not using appropriate methods of birth control.
• Use of oral contraceptives or other hormonal supplementation such as estrogen \[although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites or pregnenolone (such as estradiol) could theoretically impact the efficacy or oral contraceptives and/or estrogen replacement\]. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids such a DHEA, potentially resulting in hair, skin, or other steroid-related changes. Since the investigators' have determined in their prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely.
• Women who are breast-feeding.
• Use of narcotic interventions.
• Known allergy to study medication.
• History of moderate or severe TBI (with loss of consciousness greater than 30 minutes)
• A clearly defined disease entity that accounts for the Veteran's symptoms.
• Current DSM-IV/DSM-IVTR/DSM-V diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, or dementia.
• Subjects with a DSM-IV/DSM-IVTR/DSM-V diagnosis of alcohol or substance dependence (other than nicotine or caffeine) within the last month.
• Subjects with a current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern.
• If in the judgment of the PI it is not in the subject's best interest to participate.
• Final eligibility decisions will be determined by the PI.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Fatigue; Musculoskeletal Pain; Cognitive Dysfunction

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Results Point of Contact

• Title: Christine Marx, MD MA
• Organization: Durham VA Medical Center

marx0001@mc.duke.edu

919-286-0411

Study Officials

• Christine E. Marx, MD MA

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)