Phase 3 Study of MAP0004 in Adult Migraineurs (FREEDOM301)

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.

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: MAP0004; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 902
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Pain and Headache Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Allergan
• Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
• Investigators: Study Director: Medical Director, MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 26, 2008

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: MAP0004 CL P301