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A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache

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: NCT01946126
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.

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

Study Design
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Study Type : Observational
Actual Enrollment : 459 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : March 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic Migraine Diagnosis
This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
 Other: No Intervention
There is no intervention in this study.
Other Headache Diagnoses
This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
 Other: No Intervention
There is no intervention in this study.


Outcome Measures
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Primary Outcome Measures :
  1. Presence or Absence of Prophylactic Medication for Headache/Migraine [ Time Frame: 15 Months ]
    The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.


Secondary Outcome Measures :
  1. Number of Unique Prophylactic Medications for Headache/Migraine Reported [ Time Frame: 15 Months ]
    The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.

  2. Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches [ Time Frame: 15 Months ]
    The number of headache days is reported at the visit with the highest number of headaches.

  3. Highest Number of Headache Days Per Month at a Qualifying Visit [ Time Frame: 15 Months ]
    The highest number of headache days per month are reported at a qualifying visit per the medical record.

  4. Number of Visits for Headache Diagnosis [ Time Frame: 15 Months ]
    The number of visits for headache diagnosis is evaluated through the study period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.
Criteria

Inclusion Criteria:

  • Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months
  • Eight (8) headache days per month for at least 1 of the preceding 15 months

Exclusion Criteria:

  • Not currently diagnosed with chronic migraine, headache or migraine
  • History of receiving botulinum toxin injections for the treatment of chronic migraine.
Contacts and Locations
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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): NCT01946126


Locations
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United States, North Carolina
Raleigh, North Carolina, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01946126    
Other Study ID Numbers: GMA-BTX-CM-13-592
First Posted: September 19, 2013    Key Record Dates
Results First Posted: March 15, 2016
Last Update Posted: March 15, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations