Allopregnanolone for Traumatic Brain Injury

(ALLO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Christine E Marx, MD MA

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study will determine if allopregnanolone (ALLO) improves depression and pain symptoms in patients who have a history of mild traumatic brain injury (TBI) \[primary endpoints\]. The investigators will also determine if ALLO improves functional outcome \[secondary endpoint\]. Participants in this study will receive an intravenous infusion of either ALLO or placebo. Behavioral assessments will be conducted during the infusion and at several time points post-infusion.

Eligibility Criteria

This trial is for U.S. Military veterans aged 21-62 who have had a mild traumatic brain injury since 2001 and suffer from moderate depression (HAM-D score of at least 14) and musculoskeletal pain (BPI rating of at least 4). Participants must not be planning to change psychiatric medications or treatments during the study.

Inclusion Criteria

You have symptoms of psychosis, like seeing or hearing things that aren't there.

I experience confusion or disorientation.

My other health conditions are under control with medication.

Exclusion Criteria

I haven't used benzodiazepines, barbiturates, or opioids in the last 2 weeks.

I haven't been hospitalized for a serious illness in the last month and can manage my health conditions at home.

I am not pregnant or breast-feeding.

Treatment Details

Interventions

• Allopregnanolone (Neurosteroid)
• Placebo (Other)

Trial Overview The trial tests whether allopregnanolone, given through an IV, can help with depression and pain in those with past mild TBI. It compares this treatment against a placebo. The main goal is to see if it improves mood and pain, with a secondary focus on overall function.

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)

Group II: ALLO 50 nM Experimental Treatment 1 Intervention

ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)

Group III: ALLO 150 nM Experimental Treatment 1 Intervention

ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)

Allopregnanolone is already approved in United States for the following indications:

🇺🇸 Approved in United States as Zulresso for:

• Postpartum depression

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Durham VA Medical Center, Durham, NC Durham, NC

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References