NCT00735085

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

A Randomized, Double Blind, Placebo-Controlled Dose Escalation Study to Investigate the Safety and Pharmacokinetics After Single and Multiple Doses of SLV334 in Sequential Cohorts of Patients With Moderate and Severe Traumatic Brain Injury

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Abbott Products · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	SLV334	1000mg SLV334 as a single dose
DRUG	SLV334	1000mg SLV334 b.i.d. for one day
DRUG	SLV334	2000mg SLV334 b.i.d. for one day
DRUG	SLV334	2000mg SLV334 b.i.d. for three days
DRUG	Placebo	SLV334 Placebo arm

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-08-14
• Last updated: 2011-09-21

Locations

14 sites across 4 countries: United States, Israel, Italy, Spain