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

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SLV334
SLV334
SLV334
SLV334
Placebo
Sponsored by
Abbott Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Brain Injury

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 45771
  • Site Reference ID/Investigator# 45775
  • Site Reference ID/Investigator# 45770
  • Site Reference ID/Investigator# 45785
  • Site Reference ID/Investigator# 45780
  • Site Reference ID/Investigator# 45727
  • Site Reference ID/Investigator# 45726
  • Site Reference ID/Investigator# 45723
  • Site Reference ID/Investigator# 45725
  • Site Reference ID/Investigator# 45735
  • Site Reference ID/Investigator# 45731
  • Site Reference ID/Investigator# 45765
  • Site Reference ID/Investigator# 45762
  • Site Reference ID/Investigator# 45763

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SLV334

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG

Secondary Outcome Measures

PK parameters of SLV334

Full Information

First Posted
November 30, 2007
Last Updated
September 9, 2011
Sponsor
Abbott Products
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00735085
Brief Title
A Phase 2a Dose Escalation Study With SLV334 in Patients With Traumatic Brain Injury.
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 Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Terminated
Why Stopped
This study was stopped 20 May 2010 due to strategic considerations
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Products
Collaborators
Quintiles, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLV334
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SLV334
Intervention Description
1000mg SLV334 as a single dose
Intervention Type
Drug
Intervention Name(s)
SLV334
Intervention Description
1000mg SLV334 b.i.d. for one day
Intervention Type
Drug
Intervention Name(s)
SLV334
Intervention Description
2000mg SLV334 b.i.d. for one day
Intervention Type
Drug
Intervention Name(s)
SLV334
Intervention Description
2000mg SLV334 b.i.d. for three days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SLV334 Placebo arm
Primary Outcome Measure Information:
Title
Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
PK parameters of SLV334
Time Frame
up to 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Male or female patients, age between 16 and 70 years, inclusive. Sustained a closed [non-penetrating] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital; TBI diagnosed by history, clinical examination with GCS of 12 or less. Evidence of TBI confirmed by abnormalities on CT scan Clinical indication to monitor ICP Informed consent is given. Exclusion Criteria Any spinal cord injury; Pregnant or lactating women; Patients with penetrating head injury; Bilaterally fixed dilated pupils at the time of randomization; Coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose; Severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function); Known treatment with another investigational drug therapy within 30 days of injury. Life expectancy of less than 24 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Bronzowa, MD
Organizational Affiliation
Abbott Products
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 45771
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Site Reference ID/Investigator# 45775
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Site Reference ID/Investigator# 45770
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Site Reference ID/Investigator# 45785
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Site Reference ID/Investigator# 45780
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Site Reference ID/Investigator# 45727
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Site Reference ID/Investigator# 45726
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Site Reference ID/Investigator# 45723
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Site Reference ID/Investigator# 45725
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Site Reference ID/Investigator# 45735
City
Milan
Country
Italy
Facility Name
Site Reference ID/Investigator# 45731
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Site Reference ID/Investigator# 45765
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site Reference ID/Investigator# 45762
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Site Reference ID/Investigator# 45763
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain

12. IPD Sharing Statement

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

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