Staccato Loxapine in Migraine (Out Patient)

This study has been completed.
Information provided by:
Alexza Pharmaceuticals, Inc. Identifier:
First received: January 19, 2009
Last updated: August 28, 2009
Last verified: August 2009
Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.

Condition Intervention Phase
Migraine Headache
Drug: High dose
Drug: Low dose
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Pain-Relief [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain free, Nausea, Photophobia, Phonophobia [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 366
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: High dose
Staccato Loxapine 2.5 mg
Active Comparator: 2 Drug: Low dose
Staccato Loxapine 1.25 mg
Placebo Comparator: 3 Drug: Placebo
Staccato Placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00825500

United States, Missouri
Roger K. Cady
Springfield, Missouri, United States, 65807
United States, New York
Elkind Headache Center
Mount Vernon, New York, United States, 10550
United States, Rhode Island
CNS Research, Inc.
East Providence, Rhode Island, United States, 02916
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Principal Investigator: Roger K. Cady, MD Clinvest
Principal Investigator: Peter J. Bellafiore, MD CNS Research, Inc.
Principal Investigator: Arthur Elkind, MD Elkind Headache Center
  More Information

Responsible Party: Robert S. Fishman, MD, Alexza Pharmaceuticals, Inc. Identifier: NCT00825500     History of Changes
Other Study ID Numbers: AMDC-104-202  24-October-2008 
Study First Received: January 19, 2009
Last Updated: August 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Migraine headache

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents processed this record on May 26, 2016