A phase II randomised, double blind, placebo-controlled, dose finding, safety and tolerability trial of XY2405 as a treatment for traumatic brain injury - BRAIN trial

• Conditions: Moderate to Severe Traumatic Brain Injury; MedDRA version: 8.1Level: LLTClassification code 10060690Term: Traumatic brain injury

• Registration Number: EUCTR2006-002813-11-GB
• Lead Sponsor: Xytis Pharmaceuticals Sàrl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patient must fulfil the following criteria to be eligible for enrolment in this study:
- Admitted to hospital with traumatic brain injury
- Age: Legally adult, between 16 and 65 years, inclusive
- Gender: male or non-pregnant female (no childbearing potential, or negative pregnancy test)
- Head trauma within 8 hours to initiation of treatment with study drug
- Glasgow Coma Scale Score of 12 or less
- CT scan showing intracranial abnormality consistent with trauma
- Consented in accordance with local legal requirements
- Potential to benefit i.e. there is some prospect of survival

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known treatment with another investigational drug therapy within 30 days of injury

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of different doses of XY2405 when used as a treatment for acute traumatic brain injury in order to inform dose selection for a phase III trial.;Secondary Objective: To assess the effect of XY2405 on mortality, morbidity among patients with acute traumatic brain injury.<br><br>To assess PK profile in a larger population of patients.<br>;Primary end point(s): We will test the statistical null hypothesis that there is no increase in the proportion of patients with at least one serious adverse event (SAE) in those receiving XY2405 compared with those receiving placebo. In this analysis, the three XY2405 treatment groups (high, medium and low doses) will be combined and compared with the placebo group.