VAS203: Assessing Safety, Tolerabilty, PD and PK in patients with TBI

• Research type

  Research Study

• Full title

  An exploratory phase IIa study to assess safety, tolerability, pharmacodynamics and pharmacokinetics of VAS203 in patients with moderate and severe traumatic brain injury (TBI) A prospective, multicentre study in three Cohorts (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled)

• IRAS ID

  23437

• Contact name

  Antonio Belli

• Eudract number

  2009-012338-56

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Traumatic Brain Injury (TBI) is the leading cause of death and disability among young adults in developed countries, and the incidence in the elderly population is increasing. In less developed countries, the incidence of TBI is high and rapidly increasing. Nitric Oxide (NO) accumulates in the brain after TBI and is made responsible for secondary brain damage and raised Intra Cranial Pressure (ICP). VAS203 inhibits the synthesis of NO and so may help in recovery from TBI.32 patients with non-invasive, moderate to severe TBI who are able to receive first administration within 18 hours of TBI will be assessed for safety and tolerability of VAS203.Three groups of patients will be treated with three different doses of VAS203. Administration of study medication for each patient will start as soon as possible but no later than 18 hours after cerebral injury. Patients in Group 1 will receive open label VAS203. Patients in Groups 2 and 3 will be randomised to treatment with VAS203 or placebo. Follow-up assessments will be done daily for 2 or 3 days after treatment (treatment group dependant) and on Day 14; adverse events and concomitant medications will be documented throughout the study. After the clinical part of each Group is completed (including follow-up visit), safety parameters will be evaluated by a Data Monitoring Committee; and depending on the occurrence of any safety-related findings the DMC may recommend proceeding to the next treatment Group, and/or changes to proposed dosing levels. Any significant recommendations affecting the conduct of the study will be communicated to the Competent Authorities and Ethics Committees as appropriate.Naturally In addition to the study treatment, each patient will receive the best "standard of care"; no treatment will be withheld.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  09/H0502/80

• Date of REC Opinion

  10 Jul 2009

• REC opinion

  Further Information Favourable Opinion