Staccato Loxapine in Migraine (Out Patient)

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00825500
First received: January 19, 2009
Last updated: August 28, 2009
Last verified: August 2009
  Purpose

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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825500

Locations
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.
Investigators
Principal Investigator: Roger K. Cady, MD Clinvest/A Division of Banyan Group, Inc.
Principal Investigator: Peter J. Bellafiore, MD CNS Research, Inc.
Principal Investigator: Arthur Elkind, MD Elkind Headache Center
  More Information

No publications provided

Responsible Party: Robert S. Fishman, MD, Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov 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
Loxapine
Staccato

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Loxapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014