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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: MAP0004 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 902 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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



Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623636


Locations
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United States, Washington
Swedish Pain and Headache Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Investigators
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Study Director: Medical Director MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00623636    
Other Study ID Numbers: MAP0004 CL P301
First Posted: February 26, 2008    Key Record Dates
Results First Posted: October 29, 2013
Last Update Posted: January 9, 2014
Last Verified: December 2013
Keywords provided by Allergan:
Migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases