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NCT00825500 Clinical Trial

Staccato Loxapine in Migraine (Out Patient)

Migraine Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00825500
Other study ID # AMDC-104-202
Secondary ID 24-October-2008
Status Completed
Phase Phase 2
First received January 19, 2009
Last updated January 30, 2017
Start date January 2009
Est. completion date August 2009

Study information
Verified date August 2009
Source Alexza Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 366
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- History of migraine headache with or without aura, pain rating of Moderate or Severe (on a None-Mild- Moderate-Severe Scale) prior to dosing.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• High dose
Staccato Loxapine 2.5 mg
• Low dose
Staccato Loxapine 1.25 mg
• Placebo
Staccato Placebo

Locations
Country Name City State
United States CNS Research, Inc. East Providence Rhode Island
United States Elkind Headache Center Mount Vernon New York
United States Roger K. Cady Springfield Missouri

Sponsors (1)
Lead Sponsor Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain-Relief 2 hours
Secondary Pain free, Nausea, Photophobia, Phonophobia 2 hours
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