Condition category
Nervous System Diseases
Date applied
25/04/2006
Date assigned
12/05/2006
Last edited
12/03/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19958521

Publication citations

  1. 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.

Additional files

Editorial Notes