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An Open Label Single and Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-17299425 in Patients with Traumatic Brain Injury

Update Il y a 4 ans
Reference: EUCTR2007-000280-17

Woman and Man

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Extract

To determine whether JNJ-17299425 can reduce the increased intracranial pressure (ICP) after traumatic brain injury. The primary pharmacodynamic (PD) parameter is the reduction of ICP; the percentage reduction will be characterized, as well as the absolute reduction, and the reduction below 20 mmHg. The duration of the ICP reduction will also be analyzed. Additionally, the safety, tolerability and maximum safe dose of JNJ-17299425.

Inclusion criteria

  • Traumatic Brain Injury (TBI)

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