Phase 3 Study of MAP0004 in Adult Migraineurs

Migraine Disorders Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623636
• Other study ID #: MAP0004 CL P301
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2008
• Last updated: December 9, 2013
• Start date: July 2008
• Est. completion date: January 2011

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 902
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Swedish Pain and Headache Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 hours from time of first dose	No
Primary	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	2 hours from time of first dose	No
Primary	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	2 hours from time of first dose	No
Primary	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	2 hours from time of first dose	No
Secondary	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	From 2 to 24 hours from time of first dose	No
Secondary	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	2 hours from the first dose	No
Secondary	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	4 hours from time of first dose	No
Secondary	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	2 hours from time of first dose	No