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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

January 19, 2009
August 28, 2009
January 2009
August 2009   (final data collection date for primary outcome measure)
Pain-Relief [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00825500 on ClinicalTrials.gov Archive Site
Pain free, Nausea, Photophobia, Phonophobia [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Staccato Loxapine in Migraine (Out Patient)
A Multi-center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Outpatients With Migraine Headache

Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Migraine Headache
  • Drug: High dose
    Staccato Loxapine 2.5 mg
  • Drug: Low dose
    Staccato Loxapine 1.25 mg
  • Drug: Placebo
    Staccato Placebo
  • Active Comparator: 1
    Intervention: Drug: High dose
  • Active Comparator: 2
    Intervention: Drug: Low dose
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00825500
AMDC-104-202, 24-October-2008
No
Robert S. Fishman, MD, Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Not Provided
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
Alexza Pharmaceuticals, Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP