A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Products
• Collaborator: Quintiles, Inc.

Criteria

Inclusion Criteria

1. Male or female patients, age between 16 and 70 years, inclusive.

2. Sustained a closed [non-penetrating] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital;

3. TBI diagnosed by history, clinical examination with GCS of 12 or less.

4. Evidence of TBI confirmed by abnormalities on CT scan

5. Clinical indication to monitor ICP

6. Informed consent is given.

Exclusion Criteria

1. Any spinal cord injury;

2. Pregnant or lactating women;

3. Patients with penetrating head injury;

4. Bilaterally fixed dilated pupils at the time of randomization;

5. Coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose;

6. Severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function);

7. Known treatment with another investigational drug therapy within 30 days of injury.

8. Life expectancy of less than 24 hours.