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

Phase 2

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Drug: SLV334; Drug: Placebo

• Registration Number: NCT00735085
• Lead Sponsor: Abbott Products

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 Patients with Moderate and Severe Traumatic Brain Injury.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Study Start: 2009-04
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-09
• Disposition First Submitted: 2011-09-09
• Disposition First Submitted QC: 2011-09-09
• Last Update Submitted: 2011-09-09
• Disposition First Posted: 2011-09-21
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLV334	SLV334	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG	2 weeks

Secondary Outcome Measures

Name	Time	Method
PK parameters of SLV334	up to 4 days

Trial Locations

Locations (14)

Site Reference ID/Investigator# 45770; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 45771; 🇺🇸 Baltimore, Maryland, United States

Site Reference ID/Investigator# 45735; 🇮🇹 Milan, Italy

Site Reference ID/Investigator# 45727; 🇮🇱 Haifa, Israel

Site Reference ID/Investigator# 45725; 🇮🇱 Tel Aviv, Israel

Site Reference ID/Investigator# 45731; 🇮🇹 Monza, Italy

Site Reference ID/Investigator# 45726; 🇮🇱 Jerusalem, Israel

Site Reference ID/Investigator# 45723; 🇮🇱 Ramat Gan, Israel

Site Reference ID/Investigator# 45785; 🇺🇸 Pittsburgh, Pennsylvania, United States

Site Reference ID/Investigator# 45775; 🇺🇸 Dayton, Ohio, United States

Site Reference ID/Investigator# 45780; 🇺🇸 Pittsburgh, Pennsylvania, United States

Site Reference ID/Investigator# 45763; 🇪🇸 Palma de Mallorca, Spain

Site Reference ID/Investigator# 45765; 🇪🇸 Barcelona, Spain

Site Reference ID/Investigator# 45762; 🇪🇸 Madrid, Spain