Conditions: Patients With Schizophrenia and Acute Agitation
Keywords: schizophrenia, agitation, inhaled loxapine, ADASUVE
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 344
Healthy volunteers: no

Brief summary:
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

Detailed description:
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Arms:
arm 1: Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours arm 2: Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours arm 3: Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours

Interventions: intervention 1: Inhaled loxapine 5 mg intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled placebo
Intervention descriptions: intervention 1: Inhaled loxapine 5 mg intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled placebo

Protocol document: