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Phase 3 Study of MAP0004 in Adult Migraineurs (FREEDOM301)

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ClinicalTrials.gov Identifier: NCT00623636
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : October 29, 2013
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE February 7, 2008
First Posted Date  ICMJE February 26, 2008
Results First Submitted Date  ICMJE August 19, 2013
Results First Posted Date  ICMJE October 29, 2013
Last Update Posted Date January 9, 2014
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • Number of Subjects With Pain Relief at 2 Hours From Time of First Dose [ Time Frame: 2 hours from time of first dose ]
    Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
  • Number of Subjects Photophobia Free at 2 Hours From Time of First Dose [ Time Frame: 2 hours from time of first dose ]
    Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
  • Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose [ Time Frame: 2 hours from time of first dose ]
    Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
  • Number of Subjects Nausea Free at 2 Hours From Time of First Dose [ Time Frame: 2 hours from time of first dose ]
    Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
headache pain relief and associated symptom relief [ Time Frame: 2 hours and other specified timepoints (from 10 minutes to 48 hours). ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • Number of Subjects With Sustained Pain Relief From 2 to 24 Hours [ Time Frame: From 2 to 24 hours from time of first dose ]
    Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
  • Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours [ Time Frame: 2 hours from the first dose ]
    The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
  • Number of Subjects With Pain Relief at 4 Hours [ Time Frame: 4 hours from time of first dose ]
    Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
  • Number of Subjects With Pain Relief at 10 Minutes [ Time Frame: 2 hours from time of first dose ]
    Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
FEV1 DLco ECHO [ Time Frame: up to 6 and up to 12 months of exposure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of MAP0004 in Adult Migraineurs
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE
  • Drug: MAP0004
    MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.
  • Drug: Placebo
    Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.
Study Arms  ICMJE
  • Experimental: MAP0004
    MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
    Intervention: Drug: MAP0004
  • Placebo
    Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.
    Interventions:
    • Drug: MAP0004
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2013)
902
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2008)
950
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00623636
Other Study ID Numbers  ICMJE MAP0004 CL P301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Investigators  ICMJE
Study Director: Medical Director MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan
PRS Account Allergan
Verification Date December 2013

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