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

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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 Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Migraine Disorders
Headache
Intervention Other: No Intervention
Enrollment 459
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses
Hide Arm/Group Description This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Period Title: Overall Study
Started 184 275
Completed 184 275
Not Completed 0 0
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses Total
Hide Arm/Group Description This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study. Total of all reporting groups
Overall Number of Baseline Participants 184 275 459
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 184 participants 275 participants 459 participants
45.02  (11.54) 45.44  (11.62) 45.3  (11.58)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 184 participants 275 participants 459 participants
NA [1]  NA [1]  NA [2] 
[1]
Gender was not collected in this study.
[2]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Presence or Absence of Prophylactic Medication for Headache/Migraine
Hide Description The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.
Time Frame 15 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses
Hide Arm/Group Description:
This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Overall Number of Participants Analyzed 184 275
Measure Type: Number
Unit of Measure: Participants
Presence of Prophylactic Medication 166 227
Absence of Prophylactic Medication 18 48
2.Secondary Outcome
Title Number of Unique Prophylactic Medications for Headache/Migraine Reported
Hide Description The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.
Time Frame 15 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses
Hide Arm/Group Description:
This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Overall Number of Participants Analyzed 184 275
Mean (Standard Deviation)
Unit of Measure: Medications
2.7  (1.49) 1.8  (1.27)
3.Secondary Outcome
Title Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches
Hide Description The number of headache days is reported at the visit with the highest number of headaches.
Time Frame 15 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses
Hide Arm/Group Description:
This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Overall Number of Participants Analyzed 184 275
Mean (95% Confidence Interval)
Unit of Measure: Headache Days
22.0
(20.6 to 23.4)
19.2
(18.2 to 20.2)
4.Secondary Outcome
Title Highest Number of Headache Days Per Month at a Qualifying Visit
Hide Description The highest number of headache days per month are reported at a qualifying visit per the medical record.
Time Frame 15 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects with data for this outcome measure
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses
Hide Arm/Group Description:
This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Overall Number of Participants Analyzed 133 183
Mean (95% Confidence Interval)
Unit of Measure: Days
16.28
(14.4 to 18.2)
14.01
(12.6 to 15.4)
5.Secondary Outcome
Title Number of Visits for Headache Diagnosis
Hide Description The number of visits for headache diagnosis is evaluated through the study period.
Time Frame 15 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses
Hide Arm/Group Description:
This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
Overall Number of Participants Analyzed 184 275
Mean (Standard Deviation)
Unit of Measure: Visits
4.7  (2.5) 3.5  (1.63)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events (AEs) and serious adverse events (SAEs) were not collected in this study.
 
Arm/Group Title Chronic Migraine Diagnosis Other Headache Diagnoses
Hide Arm/Group Description This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
All-Cause Mortality
Chronic Migraine Diagnosis Other Headache Diagnoses
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Chronic Migraine Diagnosis Other Headache Diagnoses
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chronic Migraine Diagnosis Other Headache Diagnoses
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01946126    
Other Study ID Numbers: GMA-BTX-CM-13-592
First Submitted: September 17, 2013
First Posted: September 19, 2013
Results First Submitted: October 29, 2015
Results First Posted: March 15, 2016
Last Update Posted: March 15, 2016