NCT00825500

Staccato Loxapine in Migraine (Out Patient)

A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DRUG	Inhaled Placebo	Inhaled Staccato placebo (0 mg)
DRUG	Inhaled Loxapine 1.25 mg	Inhaled Staccato Loxapine 1.25 mg, single dose
DRUG	Inhaled Loxapine 2.5 mg	Inhaled Staccato Loxapine 1.25 mg, single dose

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-01-21
• Last updated: 2017-04-24
• Results posted: 2017-04-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study