A Randomized, Double blind, PlaceboControlled 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. - ND

Solvay Pharmaceuticals B.V.0 个研究点目标入组 72 人开始时间: 2009年11月27日最近更新: 2012年3月19日

研究概览

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•1. Male or female subjects, age between 16 and 70 years, inclusive (the lower age limit will be 18 if required by local regulations); 2. TBI diagnosed by history, clinical examination with Glasgow Coma Scale (GCS) of 12 or less; 3. Evidence of TBI confirmed by abnormalities on Computed Tomography (CT scan); 4. Clinical indication to monitor ICP; 5. Randomization and drug treatment with study drug possible within 8 hours after closed (non-penetrating) head trauma; 6. Informed Consent is given
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Life expectancy of less than 24 hours; 2. Any spinal cord injury; 3. Suspected or confirmed pregnancy or lactating women; 4. Penetrating head injury (e.g.missile, gunshot or stab injuries); 5. Bilaterally fixed dilated pupils at the time of randomization; 6. Coma suspected to be primarily due to other causes than head injury (e.g.drug or alcohol overdose); 7. Pure epidural hematoma (lucid interval and absence of structural brain damage on CT scan); 8. Known or CT scan evidence of previous major cerebral damage or known clinical sequelae of prior spinal cord injury; 9. Any severe concomitant condition (e.g.cancer, renal, hepatic, coronary disease or major psychiatric disorder) that can be ascertained at admission and could affect functional outcome; 10. Severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function); 11. Severe cardiac or hemodynamic instability after resuscitation (Systolic blood pressure ≤ 100mmHg)consistent with point 1 above; 12. Known treatment with another investigational drug therapy or intervention within 30 days of injury.

发起方

Solvay Pharmaceuticals B.V.