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

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.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: SLV334; Drug: SLV334; Drug: SLV334; Drug: SLV334; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Site Reference ID/Investigator# 45727
  • Jerusalem, Israel, 91120
    • Site Reference ID/Investigator# 45726
  • Ramat Gan, Israel, 52621
    • Site Reference ID/Investigator# 45723
  • Tel Aviv, Israel, 64239
    • Site Reference ID/Investigator# 45725
• Italy
  • Milan, Italy
    • Site Reference ID/Investigator# 45735
  • Monza, Italy, 20052
    • Site Reference ID/Investigator# 45731
• Spain
  • Barcelona, Spain, 08035
    • Site Reference ID/Investigator# 45765
  • Madrid, Spain, 28041
    • Site Reference ID/Investigator# 45762
  • Palma de Mallorca, Spain, 07014
    • Site Reference ID/Investigator# 45763
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Site Reference ID/Investigator# 45771
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Site Reference ID/Investigator# 45775
  • Oregon
    • Portland, Oregon, United States, 97232
      • Site Reference ID/Investigator# 45770
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Site Reference ID/Investigator# 45785
    • Pittsburgh, Pennsylvania, United States, 15213
      • Site Reference ID/Investigator# 45780

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Male or female patients, age between 16 and 70 years, inclusive.
2. Sustained a closed [non-penetrating] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital;
3. TBI diagnosed by history, clinical examination with GCS of 12 or less.
4. Evidence of TBI confirmed by abnormalities on CT scan
5. Clinical indication to monitor ICP
6. Informed consent is given.

Exclusion Criteria

1. Any spinal cord injury;
2. Pregnant or lactating women;
3. Patients with penetrating head injury;
4. Bilaterally fixed dilated pupils at the time of randomization;
5. Coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose;
6. Severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function);
7. Known treatment with another investigational drug therapy within 30 days of injury.
8. Life expectancy of less than 24 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; SLV334 Placebo arm
Experimental: SLV334	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameters of SLV334	up to 4 days

Collaborators and Investigators

• Sponsor: Abbott Products
• Collaborators: Quintiles, Inc.
• Investigators: Study Director: Juliana Bronzowa, MD, Abbott Products

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: November 30, 2007
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Estimate): September 21, 2011
• Last Update Submitted That Met QC Criteria: September 9, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: S334.2.002; 2008-001409-40 (EudraCT Number)