EUCTR2006-002813-11-GBActive, not recruitingNot Applicable
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
Xytis Pharmaceuticals Sàrl0 sites400 target enrollmentStarted: November 22, 2006Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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