Status:
TERMINATED
A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.
Lead Sponsor:
Abbott Products
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief 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 Pat...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female patients, age between 16 and 70 years, inclusive.
- Sustained a closed \[non-penetrating\] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital;
- TBI diagnosed by history, clinical examination with GCS of 12 or less.
- Evidence of TBI confirmed by abnormalities on CT scan
- Clinical indication to monitor ICP
- Informed consent is given.
- Exclusion Criteria
- Any spinal cord injury;
- Pregnant or lactating women;
- Patients with penetrating head injury;
- Bilaterally fixed dilated pupils at the time of randomization;
- Coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose;
- Severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function);
- Known treatment with another investigational drug therapy within 30 days of injury.
- Life expectancy of less than 24 hours.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00735085
Start Date
April 1 2009
End Date
August 1 2010
Last Update
September 21 2011
Active Locations (14)
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1
Site Reference ID/Investigator# 45771
Baltimore, Maryland, United States, 21201
2
Site Reference ID/Investigator# 45775
Dayton, Ohio, United States, 45409
3
Site Reference ID/Investigator# 45770
Portland, Oregon, United States, 97232
4
Site Reference ID/Investigator# 45785
Pittsburgh, Pennsylvania, United States, 15212