Clinical trial NCT00735085: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Keywords: Brain Injury
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2008-08-14
Enrollment: 57
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG
timeFrame: 2 weeks
Secondary outcomes:
measure: PK parameters of SLV334
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 45771
state: Maryland
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 45775
state: Ohio
city: Portland
country: United States
facility: Site Reference ID/Investigator# 45770
state: Oregon
city: Pittsburgh
country: United States
facility: Site Reference ID/Investigator# 45785
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site Reference ID/Investigator# 45780
state: Pennsylvania
city: Haifa
country: Israel
facility: Site Reference ID/Investigator# 45727
city: Jerusalem
country: Israel
facility: Site Reference ID/Investigator# 45726
city: Ramat Gan
country: Israel
facility: Site Reference ID/Investigator# 45723
city: Tel Aviv
country: Israel
facility: Site Reference ID/Investigator# 45725
city: Milan
country: Italy
facility: Site Reference ID/Investigator# 45735
city: Monza
country: Italy
facility: Site Reference ID/Investigator# 45731
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 45765
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 45762
city: Palma de Mallorca
country: Spain
facility: Site Reference ID/Investigator# 45763
Study officials:
affiliation: Abbott Products
name: Juliana Bronzowa, MD
role: STUDY_DIRECTOR
References: