Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

672

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2029

Conditions
Traumatic Brain Injury
Interventions
DRUG

Atorvastatin Calcium

Capsule, 80 mg/day, with no loading dose, for 28 days

DRUG

Minocycline Hydrochloride

Capsule, 200 mg loading dose on Day 1, then 100 mg twice daily for 6 days, then placebo twice daily for 21 days

DRUG

Candesartan Cilexetil

Capsule, 8 mg once on Day 1, then 16 mg daily for 27 days

DRUG

Placebo

Capsule, 2x/day for 28 days

Trial Locations (15)

15213

University of Pittsburgh, Pittsburgh

19104

University of Pennsylvania, Philadelphia

27710

Duke University Medical Center, Durham

28203

Atrium Health Wake Forest Baptist, Charlotte

37203

Vanderbilt University Medical Center, Nashville

40536

University of Kentucky, Lexington

45219

University of Cincinnati Medical Center, Cincinnati

46202

Indiana University Health, Indianapolis

53792

UW Health University Hospital, Madison

77030

Baylor College of Medicine, Houston

UTHealth Houston, Houston

78712

The University of Texas at Austin, Austin

84132

University of Utah, Salt Lake City

94110

University of California, San Francisco, San Francisco

98104

University of Washington, Seattle

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

University of California, San Francisco

OTHER