In Phase III trial, brexanolone does not benefit epilepsy patients
The Phase III STATUS trial of brexanolone has failed to meet its primary endpoint, Massachusetts, USA-based Sage Therapeutics (Nasdaq: SAGE) has revealed.
The trial was designed to study the candidate as a possible therapy for super-refractory status epilepticus (SRSE), an acute medical emergency of persistent, unremitting seizure lasting greater than five minutes.
Resolution of potentially life-threatening SRSE with brexanolone was 43.9%, compared with 42.4% for the placebo arm. All enrollees also received standard third-line anti-seizure agents.
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