A double-blind, parallel-group, Phase IIa study to investigate the efficacy, safety and pharmacokinetics of two dose levels of KN 38-7271 versus placebo in comatose patients with severe traumatic brain injury

• Conditions: Comatose patients with traumatic brain injury (TBI).

• Registration Number: EUCTR2006-001589-17-BE
• Lead Sponsor: KeyNeurotek Pharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-14
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Age 18-65 years;
2. Comatose patients with severe TBI and a Glasgow Coma Score (GCS) 3-8 as initially assessed (eg by the emergency physician) after resuscitation and hemodynamical stabilization but before intubation and/or sedation;
On arrival at the hospital the study physician should use his own judgement based on the report of the emergency doctor and the current status of the patient that the coma is due to trauma.
Patients who have a GCS >8 and/or are not comatose at the scene where the trauma occurred but deteriorate eg, during transport to the hospital may still be eligible for the study;
3. Blunt severe head trauma;
4. Hemodynamically stable (systolic blood pressure > 90 mmHg) after resuscitation/stabilization;
5. Start of treatment with study medication is feasible within 4.5 hours of onset of TBI (where onset of TBI is the time of impact. If the exact time of impact is not known, a conservative approach will be followed for the estimation of time of impact, ie, if an interval was provided for time of impact—eg, between 10:00 and 11:00 hours—the earlier end of that interval [10:00 hours] should be assumed as time of impact;
6. Informed consent obtained according to national and local legislation;
7. Negative urine pregnancy test in all female patients (as all patients are comatose and child bearing potential may not be ruled out in some women.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. TBI due to penetrating head injuries or gun shot wounds;
2. Any major spinal cord injury;
3. Initially bilateral non-reactive dilated pupils;
4. Major injury that requires/is expected to require >2500 mL of blood (> 5 blood units) within 12 hours of TBI;
Note: Patients requiring decompressive surgery may still be eligible for this study;
5. Known or CT scan evidence of previous major cerebral damage;
6. Coma due to other causes than TBI;
7. Receiving an experimental drug within 4 weeks prior to current injury;
8. Known history of disability that may interfere with further evaluation;
9. Any severe concomitant disease that may either relevantly affect the safety of the patient, the efficacy of the drug (eg, psychiatric disorders such as, but not limited to, dementia, schizophrenia, mania, personality disorders), or the metabolism of the drug (eg, severe renal or hepatic disease);
10. Patient with known hypersensitivity to any cannabinoids (CB);
11. Patients unlikely to be available for follow-up (eg, patients from abroad);
12. Patients unlikely to survive as determined by qualified study physicians before randomization;
13. Patients with known CB intake within 3 days prior to TBI.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified