The clomethiazole acute stroke study (CLASS): Safety results in 1,356 patients with acute hemispheric stroke.

The Clomethiazole Acute Stroke Study (CLASS) showed no difference in outcome between patients treated with clomethiazole or placebo for all patients treated, but a beneficial effect in patients classified as a total anterior circulation syndrome (TACS). These are patients with clinical symptoms of a large stroke. Safety and tolerability data are reported here with emphasis on the safety of treating stroke patients with a sedative drug. In total, 1,356 patients were eligible for safety analysis. Mortality at 90 days was equal between the treatment groups (clomethiazole, 19.5%; placebo, 19.7%). Clomethiazole was generally well-tolerated. The most common adverse event was sedation (clomethiazo…