Traumatic Brain Injury
Conditions
Keywords
Brain Injury
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.
Interventions
DRUGSLV334
1000mg SLV334 as a single dose
DRUGPlacebo
SLV334 Placebo arm
Sponsors
Quintiles, Inc.
Abbott Products
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of SLV334 | up to 4 days |
Countries
Israel, Italy, Spain, United States
Outcome results
None listed