Phase 3 Study of MAP0004 in Adult Migraineurs

NCT00623636 | Completed Phase 3 Results DMC

• 1 other identifier: MAP0004 CL P301
• Study Type: interventional
• Target: 902
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

Migraine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of Subjects With Sustained Pain Relief From 2 to 24 Hours

  From 2 to 24 hours from time of first dose

• Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours

  2 hours from the first dose

• Number of Subjects With Pain Relief at 4 Hours

  4 hours from time of first dose

• Number of Subjects With Pain Relief at 10 Minutes

  2 hours from time of first dose

Study Arms (2)

MAP0004

EXPERIMENTAL

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

Placebo

OTHER

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; Drug: Placebo

Interventions

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.

MAP0004; Placebo

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 and 65 years of age.
• History of episodic, acute migraine (with or without aura) with onset prior to 50

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Swedish Pain and Headache Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• 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.

  PMID: 22106843 DERIVED

• 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.

  PMID: 21964172 DERIVED

• 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.

  PMID: 21457235 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: VP, Scientific Affairs
• Organization: MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan

dkellerman@mappharma.com

650-386-3100

Study Officials

• Medical Director

  MAP Pharmaceuticals a Wholly Owned Subsidiary of Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 26, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 9, 2014
• Results First Posted: October 29, 2013

Record last verified: 2013-12

Locations

US (1)