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Multi-Drug Therapy for Traumatic Brain Injury (APT-TBI-01 Trial)
Phase 2
Waitlist Available
Led By Geoffrey Manley, MD PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks to 3 months postinjury
Summary
This trial tests if an experimental drug treatment can improve recovery from TBI compared to a control group. FDA-approved drugs are used "off-label" to see if they can help.
Who is the study for?
This trial is for adults aged 18-65 with a recent non-penetrating head injury and specific CT scan findings. Participants must have certain protein levels in their blood, be able to undergo MRI scans without sedation, use birth control if applicable, and not have severe allergies or organ dysfunction. They should also not be on the study drugs already or enrolled in another interventional study.
What is being tested?
The trial tests Atorvastatin Calcium, Minocycline Hydrochloride, Candesartan Cilexetil against a placebo to see if they improve recovery from traumatic brain injury (TBI). These FDA-approved drugs are used 'off-label' here since they're not specifically approved for TBI treatment.
What are the potential side effects?
Possible side effects include allergic reactions to the medications, liver or kidney issues due to drug intolerance, low blood pressure from Candesartan Cilexetil use, and gastrointestinal problems that could affect swallowing of the medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks to 3 months postinjury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks to 3 months postinjury
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Glasgow Outcome Scale-Extended (GOSE 2-Way)
Secondary study objectives
Blood-based biomarker (GFAP)
Change in Blood-based biomarkers (Neurofilament light chain)
Imaging biomarkers
+2 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: Intervention 1: Atorvastatin calcium (ATOR)Active Control1 Intervention
By Mouth (PO) Twice a day (BID) 80 mg/day, with no loading dose, for 28 days
Group II: Intervention 2: Minocycline hydrochloride (MINO)Active Control1 Intervention
By Mouth (PO) Twice a day (BID) 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days
Group III: Intervention 3: Candesartan cilexetil (CAND)Active Control1 Intervention
By Mouth (PO) Twice a day (BID) 8 mg once on Day 1, then 16 mg daily for 27 days
Group IV: Matching PlaceboPlacebo Group1 Intervention
By Mouth (PO) Twice a day (BID) 2 capsules 2x/day
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,583 Previous Clinical Trials
15,083,394 Total Patients Enrolled
United States Department of DefenseFED
906 Previous Clinical Trials
332,698 Total Patients Enrolled
Geoffrey Manley, MD PhDPrincipal InvestigatorUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My GFAP blood level is between 100 and 15,000 pg/ml.I am currently taking or cannot take the trial drug due to health reasons.I am between 18 and 65 years old.My liver enzymes are not more than three times the normal limit.I have a blood clot between my skull and brain.I am using effective birth control and can continue to do so during the trial.My kidney function is reduced.I have had a brain injury shown on a CT scan.I am willing and able to follow all study requirements.I cannot swallow pills.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention 1: Atorvastatin calcium (ATOR)
- Group 2: Intervention 2: Minocycline hydrochloride (MINO)
- Group 3: Intervention 3: Candesartan cilexetil (CAND)
- Group 4: Matching Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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