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Staccato Loxapine in Migraine (Out Patient)

This study has been completed.
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc. Identifier:
First received: January 19, 2009
Last updated: January 30, 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Pain free, Nausea, Photophobia, Phonophobia [ Time Frame: 2 hours ]

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   (Adult)
Sexes Eligible for Study:   All
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: Alexza Pharmaceuticals, Inc. Identifier: NCT00825500     History of Changes
Other Study ID Numbers: AMDC-104-202
Study First Received: January 19, 2009
Last Updated: January 30, 2017

Keywords provided by Alexza Pharmaceuticals, Inc.:
Migraine headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017