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

Abbott

Status and phase: Terminated; Phase 2

Conditions: Traumatic Brain Injury

Treatments: Drug: SLV334; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00735085

S334.2.002

2008-001409-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

SLV334

Experimental group

Treatment:

Drug: SLV334

Drug: SLV334

Drug: SLV334

Drug: SLV334

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo