|
ISRCTN
|
ISRCTN23625128
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A phase II, randomised, double-blind, placebo-controlled, dose-finding, safety and tolerability trial of XY2405 as a treatment for traumatic brain injury
|
|
Scientific title
|
|
|
Acronym
|
BRAIN trial
|
|
Serial number at source
|
N/A
|
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Ethics approval received 20th December, 2007.
|
|
Study design
|
Randomised, parallel-groups, double-blind, placebo-controlled study
|
|
Countries of recruitment
|
Belgium, Canada, Colombia, Czech Republic, Estonia, India, Romania, South Africa, Spain, United Kingdom
|
|
Disease/condition/study domain
|
Traumatic brain injury
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/11/2006
|
|
Anticipated end date
|
06/06/2008
|
|
Status of trial
|
Stopped |
|
Patient information material
|
|
|
Target number of participants
|
A total of 500 patients will be randomised (as of 26/09/2007 this has been updated to 400)
|
|
Interventions
|
XY2405 (anatibant) - a Bradykinin B2 receptor antagonist versus placebo
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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
|
|
Sources of funding
|
Xytis Pharmaceuticals Sàrl (UK)
|
|
Trial website
|
|
|
Publications
|
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19958521
|
|
Contact name
|
Prof
Ian
Roberts
|
|
Address
|
London School of Hygiene and Tropical Medicine
Keppel Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
WC1E 7HT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)207 958 8113
|
|
Fax
|
+44 (0)207 299 4663
|
|
Email
|
brain@lshtm.ac.uk
|
|
Sponsor
|
Xytis Pharmaceuticals Sàrl (Switzerland)
|
|
Address
|
4 Avenue Edouard Rod
|
|
City/town
|
Nyon
|
|
Zip/Postcode
|
CH-1260
|
|
Country
|
Switzerland
|
|
Sponsor website:
|
http://www.xytis.com/pharma/
|
|
Date applied
|
25/04/2006
|
|
Last edited
|
12/03/2010
|
|
Date ISRCTN assigned
|
12/05/2006
|
