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 InjuryMedDRA version: 8.1Level: LLTClassification code 10060690Term: Traumatic brain injury
- Registration Number
- EUCTR2006-002813-11-ES
- Lead Sponsor
- Xytis Pharmaceuticals Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
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
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
- Secondary Outcome Measures
Name Time Method