Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(This study was stopped 20 May 2010 due to strategic considerations)
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00735085
First received: November 30, 2007
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Drug: SLV334
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters of SLV334 [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
SLV334 Placebo arm

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735085

Locations
United States, Maryland
Site Reference ID/Investigator# 45771
Baltimore, Maryland, United States, 21201
United States, Ohio
Site Reference ID/Investigator# 45775
Dayton, Ohio, United States, 45409
United States, Oregon
Site Reference ID/Investigator# 45770
Portland, Oregon, United States, 97232
United States, Pennsylvania
Site Reference ID/Investigator# 45780
Pittsburgh, Pennsylvania, United States, 15213
Site Reference ID/Investigator# 45785
Pittsburgh, Pennsylvania, United States, 15212
Israel
Site Reference ID/Investigator# 45727
Haifa, Israel, 31096
Site Reference ID/Investigator# 45726
Jerusalem, Israel, 91120
Site Reference ID/Investigator# 45723
Ramat Gan, Israel, 52621
Site Reference ID/Investigator# 45725
Tel Aviv, Israel, 64239
Italy
Site Reference ID/Investigator# 45735
Milan, Italy
Site Reference ID/Investigator# 45731
Monza, Italy, 20052
Spain
Site Reference ID/Investigator# 45765
Barcelona, Spain, 08035
Site Reference ID/Investigator# 45762
Madrid, Spain, 28041
Site Reference ID/Investigator# 45763
Palma de Mallorca, Spain, 07014
Sponsors and Collaborators
Abbott Products
Quintiles
Investigators
Study Director: Juliana Bronzowa, MD Abbott Products
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT00735085     History of Changes
Other Study ID Numbers: S334.2.002, 2008-001409-40
Study First Received: November 30, 2007
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health

Keywords provided by Abbott:
Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014