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Neurosteroid

Allopregnanolone for Traumatic Brain Injury (ALLO Trial)

Phase 2
Waitlist Available
Led By Christine E. Marx, MD MA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
confusion or disorientation
BPI (Brief Pain Inventory, Short Form) 'current' pain intensity rating item score 4 (scale of 0-10) for musculoskeletal pain
Must not have
Female participants who are pregnant or breast-feeding
Current DSM-5 diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours, 24 hours, 7 days, and 14 days

Summary

This trial will test if allopregnanolone can improve symptoms of depression and pain in patients with a history of mild traumatic brain injury.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects are not detailed here but could include reactions related to intravenous infusions or specific effects of allopregnanolone which may affect mood, cognition, or physical well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience confusion or disorientation.
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My current pain level for musculoskeletal issues is at least a 4 out of 10.
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My pain is related to muscles or bones.
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I served in the U.S. Military after 9/11 and have had a mild traumatic brain injury since 2001.
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I have been diagnosed with major depressive disorder.
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I have lost consciousness for no more than 30 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breast-feeding.
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I have been diagnosed with bipolar disorder, schizophrenia, or another similar condition.
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I have not had seizures, stroke, prostate or other serious cancers, heart attack, heart failure, or other severe health issues.
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I am using hormonal birth control or hormone supplements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours, 24 hours, 7 days, and 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours, 24 hours, 7 days, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brief Pain Inventory, Short Form (BPI-SF) Change
Hamilton-Depression Inventory (HAM-D) Change
Secondary study objectives
Short Form Health Survey (SF-36) Change

Trial Design

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)
Group II: ALLO 50 nMExperimental Treatment1 Intervention
ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)
Group III: ALLO 150 nMExperimental Treatment1 Intervention
ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Allopregnanolone
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,656 Total Patients Enrolled
Christine E. Marx, MD MAPrincipal InvestigatorDurham VA Medical Center, Durham, NC
3 Previous Clinical Trials
362 Total Patients Enrolled
~88 spots leftby Sep 2025
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