Dexanabinol (HU-211) in the treatment of severe closed head injury: a randomized, placebo-controlled, phase II clinical trial.

Objective: To establish the safety of intravenous dexanabinol in severe head injury.

Design: Prospective, randomized, double-blind, placebo- (vehicle) controlled, multicenter, escalating dose study of a single administration of drug (48 or 150 mg) or vehicle (1 or 3 mL).

Setting: All Israeli neurosurgical intensive care units (a total of six units).