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NCT01946126 Clinical Trial

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

Headache Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01946126
Other study ID # GMA-BTX-CM-13-592
Secondary ID
Status Completed
Phase N/A
First received September 17, 2013
Last updated February 15, 2016
Start date March 2014
Est. completion date April 2014

Study information
Verified date February 2016
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 459
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
There is no intervention in this study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence or Absence of Prophylactic Medication for Headache/Migraine The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period. 15 Months No
Secondary Number of Unique Prophylactic Medications for Headache/Migraine Reported The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period. 15 Months No
Secondary Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches The number of headache days is reported at the visit with the highest number of headaches. 15 Months No
Secondary Highest Number of Headache Days Per Month at a Qualifying Visit The highest number of headache days per month are reported at a qualifying visit per the medical record. 15 Months No
Secondary Number of Visits for Headache Diagnosis The number of visits for headache diagnosis is evaluated through the study period. 15 Months No
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