Back to resultsPhase 3 Study of MAP0004 in Adult Migraineurs (FREEDOM301)
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MAP0004
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine
Eligibility 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
Sites / Locations
- Swedish Pain and Headache Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
MAP0004
Placebo
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Number of Subjects With Pain Relief at 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
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
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
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
Number of Subjects With Sustained Pain Relief From 2 to 24 Hours
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
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
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
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
Full Information
NCT ID
NCT00623636
First Posted
February 7, 2008
Last Updated
December 9, 2013
Sponsor
Allergan
Collaborators
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00623636
Brief Title
Phase 3 Study of MAP0004 in Adult Migraineurs
Acronym
FREEDOM301
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
Collaborators
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
902 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAP0004
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MAP0004
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.
Primary Outcome Measure Information:
Title
Number of Subjects With Pain Relief at 2 Hours From Time of First Dose
Description
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
Time Frame
2 hours from time of first dose
Title
Number of Subjects Photophobia Free at 2 Hours From Time of First Dose
Description
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
Time Frame
2 hours from time of first dose
Title
Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose
Description
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
Time Frame
2 hours from time of first dose
Title
Number of Subjects Nausea Free at 2 Hours From Time of First Dose
Description
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
Time Frame
2 hours from time of first dose
Secondary Outcome Measure Information:
Title
Number of Subjects With Sustained Pain Relief From 2 to 24 Hours
Description
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
Time Frame
From 2 to 24 hours from time of first dose
Title
Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours
Description
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
Time Frame
2 hours from the first dose
Title
Number of Subjects With Pain Relief at 4 Hours
Description
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
Time Frame
4 hours from time of first dose
Title
Number of Subjects With Pain Relief at 10 Minutes
Description
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
Time Frame
2 hours from time of first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Swedish Pain and Headache Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22106843
Citation
Tepper SJ, Kori SH, Borland SW, Wang MH, Hu B, Mathew NT, Silberstein SD. Efficacy and safety of MAP0004, orally inhaled DHE in treating migraines with and without allodynia. Headache. 2012 Jan;52(1):37-47. doi: 10.1111/j.1526-4610.2011.02041.x. Epub 2011 Nov 22.
Results Reference
derived
PubMed Identifier
21964172
Citation
Tepper SJ, Kori SH, Goadsby PJ, Winner PK, Wang MH, Silberstein SD, Cutrer FM. MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. Mayo Clin Proc. 2011 Oct;86(10):948-55. doi: 10.4065/mcp.2011.0093. Erratum In: Mayo Clin Proc. 2011 Dec;86(12):1248.
Results Reference
derived
PubMed Identifier
21457235
Citation
Aurora SK, Silberstein SD, Kori SH, Tepper SJ, Borland SW, Wang M, Dodick DW. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Headache. 2011 Apr;51(4):507-17. doi: 10.1111/j.1526-4610.2011.01869.x.
Results Reference
derived
Learn more about this trial
Phase 3 Study of MAP0004 in Adult Migraineurs
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