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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00735085

Run by

Abbott Products

People needed

57

Starts

2009-04-01

Expected to finish

2010-08-01

Last updated by the study team

2011-09-21

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 45771 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 45775 — Dayton, Ohio, United States
• Site Reference ID/Investigator# 45770 — Portland, Oregon, United States
• Site Reference ID/Investigator# 45785 — Pittsburgh, Pennsylvania, United States
• Site Reference ID/Investigator# 45780 — Pittsburgh, Pennsylvania, United States
• Site Reference ID/Investigator# 45727 — Haifa, Israel
• Site Reference ID/Investigator# 45726 — Jerusalem, Israel
• Site Reference ID/Investigator# 45723 — Ramat Gan, Israel
• Site Reference ID/Investigator# 45725 — Tel Aviv, Israel
• Site Reference ID/Investigator# 45735 — Milan, Italy
• Site Reference ID/Investigator# 45731 — Monza, Italy
• Site Reference ID/Investigator# 45765 — Barcelona, Spain
• Site Reference ID/Investigator# 45762 — Madrid, Spain
• Site Reference ID/Investigator# 45763 — Palma de Mallorca, Spain

Full record on ClinicalTrials.gov

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