NCT00489476

Staccato Loxapine in Migraine (in Clinic)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Staccato Loxapine
DRUG	Staccato Placebo	Placebo aerosol inhalation (0mg)

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-06-21
• Last updated: 2017-07-06
• Results posted: 2017-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study