Conditions: Migraine
Keywords: Staccato® Loxapine, Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 168
Healthy volunteers: yes

Brief summary:
The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.

Detailed description:
This study will enroll male and female patients with migraine headache with or without aura. The study will randomize \~160 patients, 1:1:1:1 to receive one of the following treatments: 1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato Placebo.

Arms:
arm 1: 1.25 mg ADASUVE, single dose arm 2: 2.5 mg ADASUVE, single dose arm 3: 5 mg ADASUVE, single dose arm 4: Staccato Placebo, 0 mg

Interventions: intervention 1: Staccato Loxapine intervention 2: Staccato Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo aerosol inhalation (0mg)

Protocol document: