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
Results First Received: January 21, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Migraine Disorders
Intervention: Other: No Treatment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study was an internet survey to identify participants with Episodic Migraine (EM) and Chronic Migraine (CM). The participants were followed for up to 1 year by assessments every 3 months.

Reporting Groups
  Description
Participants With Migraines Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.

Participant Flow:   Overall Study
    Participants With Migraines  
STARTED     16789  
COMPLETED     5915  
NOT COMPLETED     10874  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Participants With Migraines Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.

Baseline Measures
    Participants With Migraines  
Number of Participants  
[units: participants]
  16789  
Age  
[units: years]
Mean (Standard Deviation)
  40.7  (14.4)  
Gender  
[units: participants]
 
Female     12495  
Male     4294  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)   [ Time Frame: Baseline ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


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
Study First Received: July 20, 2012
Results First Received: January 21, 2015
Last Updated: January 21, 2015
Health Authority: United States: Institutional Review Board