A phase II, randomised, double-blind, placebo-controlled, dose-finding, safety and tolerability trial of XY2405 as a treatment for traumatic brain injury

ISRCTN	ISRCTN23625128
DOI	https://doi.org/10.1186/ISRCTN23625128
Secondary identifying numbers	N/A

Submission date: 25/04/2006
Registration date: 12/05/2006
Last edited: 12/03/2010

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ian Roberts
Scientific

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)207 958 8113
Email	brain@lshtm.ac.uk

Study information

Study design	Randomised, parallel-groups, double-blind, placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	BRAIN trial
Study objectives	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(s)	Ethics approval received 20th December, 2007.
Health condition(s) or problem(s) studied	Traumatic brain injury
Intervention	XY2405 (anatibant) - a Bradykinin B2 receptor antagonist versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	01/11/2006
Completion date	06/06/2008
Reason abandoned (if study stopped)	Stopped early and didn't reach full sample size.

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	A total of 500 patients will be randomised (as of 26/09/2007 this has been updated to 400)
Key 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
Key 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
Date of first enrolment	01/11/2006
Date of final enrolment	06/06/2008

Locations

Countries of recruitment

Belgium
Canada
Colombia
Czech Republic
England
Estonia
India
Romania
South Africa
Spain
United Kingdom

Study participating centre

London School of Hygiene and Tropical Medicine

London
WC1E 7HT
United Kingdom

Sponsor information

Xytis Pharmaceuticals Sàrl (Switzerland)
Industry

4 Avenue Edouard Rod
Nyon
CH-1260
Switzerland

Website	http://www.xytis.com/pharma/

Funders

Funder type

Industry

Xytis Pharmaceuticals Sàrl (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/12/2009		Yes	No