Contact information
Type
Scientific
Primary contact
Prof Ian Roberts
ORCID ID
Contact details
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)207 958 8113
brain@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BRAIN trial
Study hypothesis
This study aims to evaluate the safety of three 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.
Please note that as of 26/09/2007 this trial record was updated by the PI. The end date of this trial was extended (the previous end date of this trial was 30/04/2008). The number of participants and trial recruitment countries (Estonia was added) have also been updated. Any changes to the trial have been noted under the date 26/09/2007.
Please note that as of 31/07/2008 the end date of this trial was stopped early and did not reach its full sample size. The actual end date of this trial was therefore 06/06/2008. The anticipated end date of this trial was 30/08/2008.
Ethics approval
Ethics approval received 20th December, 2007.
Study design
Randomised, parallel-groups, double-blind, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Traumatic brain injury
Intervention
XY2405 (anatibant) - a Bradykinin B2 receptor antagonist versus placebo
Intervention type
Drug
Phase
Phase II
Drug names
XY2405
Primary outcome measure
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 outcome measures
1. To assess the effect of XY2405 on mortality, morbidity and biomarkers of blood brain barrier dysfunction among patients with acute traumatic brain injury. Mortality will be assessed two weeks following the injury. In-hospital morbidity will be assessed two weeks post injury.
2. To assess pharmacokinetic (PK) profile in a larger population of patients
Overall trial start date
01/11/2006
Overall trial end date
06/06/2008
Reason abandoned (if study stopped)
Stopped early and didn't reach full sample size.
Eligibility
Participant inclusion criteria
1. Age: legally adult, between 16 and 65 years, inclusive
2. Gender: male or non-pregnant female (no childbearing potential or negative pregnancy test)
3. Head trauma within eight hours to initiation of treatment with study drug
4.Glasgow Coma Scale Score of 12 or less
5. Computed tomography (CT) scan showing intracranial abnormality consistent with trauma
6. Consented in accordance with local legal requirements
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 500 patients will be randomised (as of 26/09/2007 this has been updated to 400)
Participant exclusion criteria
1. Patients with an extremely poor prognosis for survival based on clinical judgement
2. Known treatment with another investigational drug therapy within 30 days of injury
Recruitment start date
01/11/2006
Recruitment end date
06/06/2008
Locations
Countries of recruitment
Belgium, Canada, Colombia, Czech Republic, Estonia, India, Romania, South Africa, Spain, United Kingdom
Trial participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Xytis Pharmaceuticals Sàrl (Switzerland)
Sponsor details
4 Avenue Edouard Rod
Nyon
CH-1260
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Xytis Pharmaceuticals Sàrl (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19958521
Publication citations
-
Results
Shakur H, Andrews P, Asser T, Balica L, Boeriu C, Quintero JD, Dewan Y, Druwé P, Fletcher O, Frost C, Hartzenberg B, Mantilla JM, Murillo-Cabezas F, Pachl J, Ravi RR, Rätsep I, Sampaio C, Singh M, Svoboda P, Roberts I, The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury., Trials, 2009, 10, 109, doi: 10.1186/1745-6215-10-109.