Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Chronic Migraine Epidemiology and Outcomes Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01648530
First received: July 20, 2012
Last updated: January 21, 2015
Last verified: January 2015

July 20, 2012
January 21, 2015
July 2012
November 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.
  • Migraine Disability Assessment (MIDAS) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.
Migraine Disability Assessment (MIDAS) [ Time Frame: 13 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01648530 on ClinicalTrials.gov Archive Site
Not Provided
Subject Quality of Life Questionnaire [ Time Frame: 13 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chronic Migraine Epidemiology and Outcomes Study
Not Provided
This is a population internet-based study to characterize migraine clinical course and impact on family.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Participants with migraine
Migraine Disorders
Other: No Treatment
No Treatment
Participants with Migraines
Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
Intervention: Other: No Treatment
Adams AM, Serrano D, Buse DC, Reed ML, Marske V, Fanning KM, Lipton RB. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015 Jun;35(7):563-78. doi: 10.1177/0333102414552532. Epub 2014 Oct 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16789
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01648530
GMA-BTX-12-470
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP