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

NCT00735085 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2011-09-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Abbott Products

    lead INDUSTRY

Principal Investigators

  • Juliana Bronzowa, MD · Abbott Products

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Israel
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735085 on ClinicalTrials.gov