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

Completed

• Conditions: Traumatic brain injury; Nervous System Diseases

• Registration Number: ISRCTN23625128
• Lead Sponsor: Xytis Pharmaceuticals Sàrl (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified