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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00735085
• Other study ID #: S334.2.002
• Secondary ID: 2008-001409-40
• Status: Terminated
• Phase: Phase 2
• First received: November 30, 2007
• Last updated: September 9, 2011
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesSwitzerland: SwissmedicFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• SLV334
1000mg SLV334 as a single dose
• SLV334
1000mg SLV334 b.i.d. for one day
• SLV334
2000mg SLV334 b.i.d. for one day
• SLV334
2000mg SLV334 b.i.d. for three days
• Placebo
SLV334 Placebo arm

Locations

Country	Name	City	State
Israel	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
Italy	Site Reference ID/Investigator# 45735	Milan
Italy	Site Reference ID/Investigator# 45731	Monza
Spain	Site Reference ID/Investigator# 45765	Barcelona
Spain	Site Reference ID/Investigator# 45762	Madrid
Spain	Site Reference ID/Investigator# 45763	Palma de Mallorca
United States	Site Reference ID/Investigator# 45771	Baltimore	Maryland
United States	Site Reference ID/Investigator# 45775	Dayton	Ohio
United States	Site Reference ID/Investigator# 45780	Pittsburgh	Pennsylvania
United States	Site Reference ID/Investigator# 45785	Pittsburgh	Pennsylvania
United States	Site Reference ID/Investigator# 45770	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Products	Quintiles, Inc.

Countries where clinical trial is conducted

United States,  Israel,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG		2 weeks	Yes
Secondary	PK parameters of SLV334		up to 4 days	No