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

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.
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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. |
- 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
- 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

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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 |
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

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
United States, Washington | |
Swedish Pain and Headache Clinic | |
Seattle, Washington, United States, 98104 |
Study Director: | Medical Director | MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan |
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 |
Migraine |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |