The study is designed to determine the safety and efficacy of Progesterone in patients with severe head injury

• Conditions: Severe traumatic brain injury; MedDRA version: 17.0Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-018283-16-FI
• Lead Sponsor: BHR Pharma, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-03
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1180

Inclusion Criteria

1.Male or female patients, age between 16 and 70 years, inclusive (or lower age limit as required by local regulations)
2.Weight from 45 to 135 kg, inclusive.
3.Sustained a closed head trauma no more than 8 hours before initiation of study drug infusion (exposed dura mater is acceptable in the
case of depressed skull fractures)
4.TBI diagnosed by history and clinical examination
5. GCS score between 3 to 8, inclusive
6.At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
7.Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (Diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall’s CT Classification)
8.Indication for ICP monitoring
Are the trial subjects under 18? yes
Number of subjects for this age range: 23
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1062
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

1.Life expectancy of less than 24 hours as determined by the Investigator
2.Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of Randomization.
3.Any spinal cord injury
4.Pregnancy
5.Penetrating head injury
6.Bilaterally fixed dilated pupils at the time of randomization
7.Coma suspected to be primarily due to other causes (e.g. alcohol)
8.Pure epidural hematoma
9.Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
10.Severe cardiac or hemodynamic instability after resuscitation prior to randomization.
11.Known treatment with another investigational drug, device, medical therapy or procedure within 30 days of injury.
12.A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
13.Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
14.Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit ( 6 months post-injury)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to determine the efficacy and safety of BHR-100 utilizing the 6-month GOS in severe TBI patients (GCS 3-8) following 120 hours of study treatment.;Secondary Objective: In addition, the clinical benefit of progesterone treatment will be further assessed through the evaluation of:<br>1.Mortality at 1 month and 6 months post injury<br>2.GOS at 3 months <br>3.GOS-E at 3 and 6 months<br>4.Quality of Life using Short Form (36) Health Survey (SF-36) at 3 and 6 months<br>5.The effect on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL)<br>6.The effect on the progression of intracranial pathology as assessed by admission and Day 6 (+/- 1 Day) computed tomography (CT) scans <br>;Primary end point(s): GOS evaluated at 6 months post injury.;Timepoint(s) of evaluation of this end point: Month 6 post-injury.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Mortality assessment at 1 month and 6 months post TBI<br>• Evaluation of GOS at 3 months<br>• Evaluation of the GOS-E at Months 3 and 6<br>• SF-36 at Months 3 and 6<br>• Changes in ICP, CPP and TIL<br>• Effect of treatment on the progression of intracranial pathology as assesses by admission (baseline) and end-infusion (Day6+/-1 Day) CT scans;Timepoint(s) of evaluation of this end point: •Month 1 (mortality)<br>•Month 3 (GOS, GOS-E, SF-36)<br>•Month 6 (mortality, GOS-E, SF-36)