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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

Tracking Information
First Submitted Date September 17, 2013
First Posted Date September 19, 2013
Results First Submitted Date October 29, 2015
Results First Posted Date March 15, 2016
Last Update Posted Date March 15, 2016
Study Start Date March 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2016)
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.
Original Primary Outcome Measures
 (submitted: September 18, 2013)
Presence or Absence of Prophylactic Medication for Headache [ Time Frame: 18 Months ]
Change History
Current Secondary Outcome Measures
 (submitted: February 15, 2016)
  • 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.
  • 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.
  • 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.
  • Number of Visits for Headache Diagnosis [ Time Frame: 15 Months ]
    The number of visits for headache diagnosis is evaluated through the study period.
Original Secondary Outcome Measures
 (submitted: September 18, 2013)
  • Medication Use for the Prevention and Treatment of Migraine [ Time Frame: 18 months ]
  • Number of Headache Days per 30 Day Period [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache
Official Title Not Provided
Brief Summary This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.
Condition
  • Migraine Disorders
  • Headache
Intervention Other: No Intervention
There is no intervention in this study.
Study Groups/Cohorts
  • Chronic Migraine Diagnosis
    This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
    Intervention: Other: No Intervention
  • 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.
    Intervention: Other: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 26, 2014)
459
Original Estimated Enrollment
 (submitted: September 18, 2013)
200
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01946126
Other Study ID Numbers GMA-BTX-CM-13-592
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date February 2016