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Completed

NCT Number: NCT00623636

Phase 3 Study of MAP0004 in Adult Migraineurs

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Swedish Pain and Headache Clinic

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAP0004

Drug

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

Drug

Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Registry information

Official study 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.

Acronym: FREEDOM301

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 26, 2008
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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