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 |
| Protocol serial number | N/A |
| Sponsor | Xytis Pharmaceuticals Sàrl (Switzerland) |
| Funder | Xytis Pharmaceuticals Sàrl (UK) |
- 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
Scientific
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)207 958 8113 |
|---|---|
| brain@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, parallel-groups, double-blind, placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | XY2405 |
| 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 |
| Key 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. |
| 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 | All |
| Target sample size at registration | 500 |
| 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
- United Kingdom
- England
- Belgium
- Canada
- Colombia
- Czech Republic
- Estonia
- India
- Romania
- South Africa
- Spain
Study participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
