NCT00735085

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
4 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2007

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

1.3 years

First QC Date

November 30, 2007

Last Update Submit

September 9, 2011

Conditions

Traumatic Brain Injury

Keywords

Brain Injury

Outcome Measures

Primary Outcomes (1)

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

    2 weeks

Secondary Outcomes (1)

  • PK parameters of SLV334

    up to 4 days

Study Arms (2)

SLV334

EXPERIMENTAL
Drug: SLV334

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SLV334DRUG

1000mg SLV334 as a single dose

SLV334
PlaceboDRUG

SLV334 Placebo arm

Placebo

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Site Reference ID/Investigator# 45771

Baltimore, Maryland, 21201, United States

Location

Site Reference ID/Investigator# 45775

Dayton, Ohio, 45409, United States

Location

Site Reference ID/Investigator# 45770

Portland, Oregon, 97232, United States

Location

Site Reference ID/Investigator# 45785

Pittsburgh, Pennsylvania, 15212, United States

Location

Site Reference ID/Investigator# 45780

Pittsburgh, Pennsylvania, 15213, United States

Location

Site Reference ID/Investigator# 45727

Haifa, 31096, Israel

Location

Site Reference ID/Investigator# 45726

Jerusalem, 91120, Israel

Location

Site Reference ID/Investigator# 45723

Ramat Gan, 52621, Israel

Location

Site Reference ID/Investigator# 45725

Tel Aviv, 64239, Israel

Location

Site Reference ID/Investigator# 45735

Milan, Italy

Location

Site Reference ID/Investigator# 45731

Monza, 20052, Italy

Location

Site Reference ID/Investigator# 45765

Barcelona, 08035, Spain

Location

Site Reference ID/Investigator# 45762

Madrid, 28041, Spain

Location

Site Reference ID/Investigator# 45763

Palma de Mallorca, 07014, Spain

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Juliana Bronzowa, MD

    Abbott Products

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2007

First Posted

August 14, 2008

Study Start

April 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations

IL(4)ES(3)US(5)IT(2)