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Phase 3 Study of MAP0004 in Adult Migraineurs (FREEDOM301)

This study has been completed.
Sponsor:
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00623636
First received: February 7, 2008
Last updated: February 17, 2011
Last verified: February 2011
History of Changes

February 7, 2008
February 17, 2011
July 2008
December 2010   (final data collection date for primary outcome measure)
headache pain relief and freedom from associated symptoms. [ Time Frame: 2 hours and other specified timepoints. ] [ Designated as safety issue: No ]
headache pain relief and associated symptom relief [ Time Frame: 2 hours and other specified timepoints (from 10 minutes to 48 hours). ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00623636 on ClinicalTrials.gov Archive Site
Pain relief in 10 mnts, sustained pain relief 2-24 hours, Long term safety [ Time Frame: up to 12 months of exposure ] [ Designated as safety issue: No ]
FEV1 DLco ECHO [ Time Frame: up to 6 and up to 12 months of exposure ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 3 Study of MAP0004 in Adult Migraineurs
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.

This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Migraine
  • Drug: MAP0004
    inhalation for Single attack
    Other Name: MAP0004
  • Drug: Placebo
    Placebo for MAP0004
    Other Name: Placebo
  • Experimental: Double Blind
    MAP0004 or Placebo - the double blind portion of the study is completed and not recruiting
    Interventions:
    • Drug: MAP0004
    • Drug: Placebo
  • Experimental: Open Label
    MAP0004 - this arm is active but not recruiting
    Intervention: Drug: MAP0004
  • Experimental: Open Label - Asthmatics
    MAP0004 - this arm is active but not recruiting
    Intervention: Drug: MAP0004
  • No Intervention: Control Group
    This arm is active but no longer recruiting

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1195
January 2011
December 2010   (final data collection date for primary outcome measure)

Major Inclusion Criteria:

  • Male or female between 18 and 65 years of age.
  • History of episodic, acute migraine (with or without aura) with onset prior to 50

Major Exclusion Criteria:

  • Known allergy or sensitivity or contraindication to study drugs or their formulations
  • History of chronic pulmonary disease, coronary artery disease (CAD),liver disease, kidney disease,seizures, stroke,or major psychiatric condition.
  • Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623636
MAP0004 CL P301
Yes
Shashidhar H Kori MD, MAP Pharmaceuticals
MAP Pharmaceuticals, Inc.
Not Provided
Study Director: Shashidhar H Kori, MD MAP Pharmaceuticals Medical Monitor
MAP Pharmaceuticals, Inc.
February 2011

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