Allopregnanolone in Chronic Complex Traumatic Brain Injury
ConditionTraumatic Brain Injury (TBI)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-62
SponsorVA Office of Research and Development
About 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 does not accept healthy volunteersQualifiers
Any ethnic group
History of mild traumatic brain injury (TBI) since 2001 and service in the U.S. Military since 9/11/01 (OEF/OIF/OND era)
confusion or disorientation
loss of consciousness for 30 minutes or less
Disqualifiers
Participants with current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern
Medications that could potentially confound study outcomes (for example, prednisone) are exclusionary
Current DSM-5 diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI
Female participants who are pregnant or breast-feeding
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugALLO 0 nanomolar (nM) (placebo: loading dose, 4-hour infusion, taper)
Allopregnanolone
DrugALLO 50 nanomolar (nM) (lower dose ALLO: loading dose, 4 hour infusion, taper)
Allopregnanolone
DrugALLO 150 nanomolar (nM) (higher dose ALLO: loading dose, 4 hour infusion, taper)
Treatment groups
132 Participants
are divided into 3 treatment groupsGroup A: PlaceboExperimental treatment 1 intervention
Group B: ALLO 50 nanomolar (nM)Experimental treatment 1 intervention
Group C: ALLO 150 nanomolar (nM)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Brief Pain Inventory, Short Form (BPI-SF) Change
The Brief Pain Inventory, Short Form (BPI-SF) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame
6 hours, 24 hours, 7 days, and 14 days2
Hamilton-Depression Inventory (HAM-D) Change
The HAM-D measures the severity of depressive symptoms. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.
Time frame
6 hours, 24 hours, 7 days, and 14 daysSecondary outcomes
1
Short Form Health Survey (SF-36) Change
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 are set at 0 and 100, respectively. All of these items are scored so that a high score defines a more favorable health state.
Time frame
6 hours, 24 hours, 7 days, and 14 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: