Chronic Migraine Epidemiology and Outcomes Study

Migraine Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648530
• Other study ID #: GMA-BTX-12-470
• Status: Completed
• Phase: N/A
• First received: July 20, 2012
• Last updated: January 21, 2015
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a population internet-based study to characterize migraine clinical course and impact on family.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16789
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• History of migraine

• U.S. Member of Survey Panel

• Household member of study participant

• Ability to complete internet-based questionnaires

Exclusion Criteria:

• No access to internet

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Other:
• No Treatment
No Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)	EM is defined as <15 headache days/month and CM is defined as =15 headache days/month.	Baseline	No
Primary	Migraine Disability Assessment (MIDAS)	The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged.	12 Months	No