Staccato Loxapine in Migraine (Out Patient)

Phase 2

Completed

• Conditions: Migraine Headache
• Interventions: Drug: Inhaled Loxapine 1.25 mg; Drug: Inhaled Loxapine 2.5 mg; Drug: Inhaled Placebo

• Registration Number: NCT00825500
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-19
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2017-03-13
• Results First Submitted QC: 2017-03-13
• Last Update Submitted: 2017-03-13
• Results First Posted: 2017-04-24
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled Loxapine 1.25 mg	Inhaled Loxapine 1.25 mg	Inhaled Staccato Loxapine 1.25 mg, single dose
Inhaled Loxapine 2.5 mg	Inhaled Loxapine 2.5 mg	Inhaled Staccato Loxapine 2.5 mg, single dose
Inhaled Placebo	Inhaled Placebo	Inhaled Staccato Placebo (0 mg)

Primary Outcome Measures

Name	Time	Method
Pain-Relief at 2 Hours Post-treatment	2 hours	Pain-Relief=pretreatment pain rating of 2 (moderate) or 3 (severe) and a rating of 0 (none) or 1 (mild) at the designated assessment time

Secondary Outcome Measures

Name	Time	Method
Photophobia Free	2 hours	Free of Photophobia at 2 Hours Post-treatment

Trial Locations

Locations (3)

CNS Research, Inc.; 🇺🇸 East Providence, Rhode Island, United States

Roger K. Cady; 🇺🇸 Springfield, Missouri, United States

Elkind Headache Center; 🇺🇸 Mount Vernon, New York, United States