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

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ClinicalTrials.gov Identifier: NCT00735085
Recruitment Status : Terminated (This study was stopped 20 May 2010 due to strategic considerations)
First Posted : August 14, 2008
Last Update Posted : September 21, 2011
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Abbott ( Abbott Products )

Brief 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: SLV334 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. PK parameters of SLV334 [ Time Frame: up to 4 days ]


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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# 45785
Pittsburgh, Pennsylvania, United States, 15212
Site Reference ID/Investigator# 45780
Pittsburgh, Pennsylvania, United States, 15213
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, Inc.
Investigators
Study Director: Juliana Bronzowa, MD Abbott Products

Responsible Party: Abbott Products
ClinicalTrials.gov Identifier: NCT00735085     History of Changes
Other Study ID Numbers: S334.2.002
2008-001409-40 ( EudraCT Number )
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011

Keywords provided by Abbott ( Abbott Products ):
Brain Injury

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