Traumatic brain injury Nervous System Diseases Traumatic brain injury
Conditions
Interventions
XY2405 (anatibant) - a Bradykinin B2 receptor antagonist versus placebo
Sponsors
Xytis Pharmaceuticals Sàrl (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Canada, Colombia, Czech Republic, Estonia, India, Romania, South Africa, Spain, United Kingdom
Outcome results
None listed