Phase 3 Study of Progesterone in Patients with Traumatic Brain Injury
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients with Severe Traumatic Brain Injury
IRAS ID
53621
Contact name
Antonio Belli
Sponsor organisation
BHR Pharama, LLC
Eudract number
2010-018283-16
Clinicaltrials.gov Identifier
Research summary
A RANDOMISED,DOUBLE-BLIND,PLACEBO-CONTROLLED PHASE 3 STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PROGESTERONE IN PATIENTS WITH SEVERE TRAUMATIC BRAIN INJURYTraumatic brain injury (TBI) is a form of acquired brain injury which occurs when a sudden trauma causes damage to the brain. Causes include falls, vehicle accidents, and violence. TBI is a major cause of death and disability worldwide, especially in children and young adults. Each year in England and Wales, around 700,000 people attend hospital accident and emergency (A&E) departments with a head injury. While most of these are minor head injuries, around 10% are moderate or severe head injuries. Many patients have long-term or life-long need for help to perform activities of daily living as a result of TBI. TBI can cause a host of physical, cognitive, emotional, and behavioral effects, and outcome can range from complete recovery to permanent disability or death.This study is investigating a new treatment for severe TBI. The active ingredient of the study drug (BHR-100) is progesterone (a gonadal hormone). Progesterone has been seen to have neuroprotective properties (protects nerves from degeneration) in clinical studies and is thought to play an important role in promoting and enhancing repair after TBI. In this study, the safety and efficacy of BHR-100 will be compared to placebo, with the treatment administered by intravenous infusion within 8 hours of the TBI for a total of 120 hours. Participants will be assigned randomly to each treatment equally, and will be assessed using neurological scales to monitor the participant's functioning. The final assessment will be completed 6 months post-injury.Approximately, 1180 patients between the ages of 16 to 70, both male and female, in over 100 sites in North America, Europe, Asia and South America are planned to be enrolled in this study.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
10/H0502/59
Date of REC Opinion
26 Aug 2010
REC opinion
Favourable Opinion