Allopregnanolone for the Treatment of Traumatic Brain Injury

Completed · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury, Posttraumatic Epilepsy

In brief

This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.

Key facts

Study ID

NCT01673828

Run by

Michael A. Rogawski, MD, PhD

People needed

13

Starts

2013-04-01

Expected to finish

2016-07-01

Last updated by the study team

2017-06-28

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• English or Spanish speaking person
• Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12]
• Less than 8 hours from injury to study initiation
• Able to participate for the full term of the study

You may not qualify if…

• Subjects with life expectancy of less than 24 hours
• Isolated epidural hematoma
• Hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment)
• Hypotension (systolic blood pressure ≤90 mm Hg on 2 or more reliable measurements before enrollment)
• Cardiopulmonary arrest prior to randomization
• Spinal cord injury with motor deficits
• Bilateral non-reactive pupils with Glasgow Coma Scale 3
• Body weight >120 kg
• Pregnancy
• Active breast or reproductive organ cancer
• Allergy to progesterone
• History of thromboembolic events
• Receipt of activated Factor VII before enrollment
• Any disease that is unstable or which could jeopardize the safety of the subject including severe renal impairment (creatinine clearance <50 ml/min)
• Prisoner/ward of the state
• Known treatment with another investigational drug therapy or procedure within 30 days of injury

Where it is running

• University of California, Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.