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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
History of Changes

November 30, 2007
September 9, 2011
April 2009
August 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00735085 on ClinicalTrials.gov Archive Site
PK parameters of SLV334 [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • 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
  • Experimental: SLV334
    Interventions:
    • Drug: SLV334
    • Drug: SLV334
    • Drug: SLV334
    • Drug: SLV334
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
57
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel,   Italy,   Spain
 
NCT00735085
S334.2.002, 2008-001409-40
Yes
Abbott ( Abbott Products )
Abbott Products
Quintiles
Study Director: Juliana Bronzowa, MD Abbott Products
Abbott
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP