Conditions: Migraine Headache
Keywords: Migraine headache Loxapine Staccato
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 366
Healthy volunteers: no

Brief summary:
Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.

Detailed description:
This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.

Arms:
arm 1: Inhaled Staccato Placebo (0 mg) arm 2: Inhaled Staccato Loxapine 1.25 mg, single dose arm 3: Inhaled Staccato Loxapine 2.5 mg, single dose

Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 1.25 mg intervention 3: Inhaled Loxapine 2.5 mg
Intervention descriptions: intervention 1: Inhaled Staccato placebo (0 mg) intervention 2: Inhaled Staccato Loxapine 1.25 mg, single dose intervention 3: Inhaled Staccato Loxapine 1.25 mg, single dose

Protocol document: