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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: SLV334
* Drug: SLV334
* Drug: SLV334
* Drug: SLV334
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLV334<br> | Drug: SLV334<br>* 1000mg SLV334 as a single dose<br>Drug: SLV334<br>* 1000mg SLV334 b.i.d. for one day<br>Drug: SLV334<br>* 2000mg SLV334 b.i.d. for one day<br>Drug: SLV334<br>* 2000mg SLV334 b.i.d. for three days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* SLV334 Placebo arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of SLV334 |  | up to 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Injury