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Chronic Migraine Epidemiology and Outcomes Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648530
First Posted: July 24, 2012
Last Update Posted: January 29, 2015
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.
Information provided by (Responsible Party):
Allergan
  Purpose
This is a population internet-based study to characterize migraine clinical course and impact on family.

Condition Intervention
Migraine Disorders Other: No Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.

  • 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.


Enrollment: 16789
Study Start Date: July 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: July 20, 2012
First Posted: July 24, 2012
Results First Submitted: January 21, 2015
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