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Chronic Migraine Epidemiology and Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01648530
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment
Migraine Disorders Other: No Treatment

Study Type : Observational
Actual Enrollment : 16789 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2012
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Group/Cohort Intervention/treatment
Participants with Migraines
Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
Other: No Treatment
No Treatment



Primary Outcome Measures :
  1. Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) [ Time Frame: Baseline ]
    EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.

  2. Migraine Disability Assessment (MIDAS) [ Time Frame: 12 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with migraine
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648530


Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01648530     History of Changes
Other Study ID Numbers: GMA-BTX-12-470
First Posted: July 24, 2012    Key Record Dates
Results First Posted: January 29, 2015
Last Update Posted: January 29, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases