VAS203/III/1/04_Nostra Phase III Trial
Research type
Research Study
Full title
EFFICACY OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY (NOSTRA Phase III trial) A confirmatory, placebo-controlled, randomised, double blind, multi-centre study.
IRAS ID
203554
Contact name
Diederik Bulters
Contact email
Sponsor organisation
vasopharm GmbH
Eudract number
2013-003368-29
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
This is a confirmatory, placebo-controlled, randomised, double blind, multi-centre study to evaluate the efficacy of the study drug VAS203 on clinical outcomes at 6 months in patients suffering from moderate to severe traumatic brain injury (TBI). TBI is the leading cause of death and disability among young adults in developed countries. Neurological damage after TBI is caused not only by the impact itself, but evolves afterwards (secondary injury). Indeed, secondary injury including raised intracranial pressure (ICP) is the major cause of death after TBI.
Nitric Oxide (NO) is one of the key factors regulating the dilation of blood vessels and is involved in inflammatory processes. It has also been demonstrated to be an important component in the development of secondary brain injury. The compound VAS203 has a structure similar to 5,6,7,8-Tetrahydro-L-biopterin (BH4), the endogenous cofactor of nitric oxide synthase (NOS) and one of the most potent inhibitors of NOS known so far. Results from the Nostra phase II trial showed a beneficial effect of VAS203 on the clinical outcomes as measured by eGOS-I (extended Glasgow Outcome Scale Interview) after 6 and 12 months. This confirmatory trial to evaluate the primary efficacy objective of the eGOS-I at 6 months after TBI.
Recruitment of patients will be continued until up to 232 patients are randomised in a ratio of 1:1 to VAS203 and placebo respectively. The study is completed with 220 evaluable patients in full analysis set.
The study will start with a Screening and Baseline period (up to 18 hours). The acute clinical period for each patient will be 14 days followed by a 6 months observation period (Post-Clinical Follow-up). At least 30 study centres will be involved (in Germany, Spain, United Kingdom, France and Austria) with back-up sites in Israel.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0197
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion