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This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Migraine Diagnosis | This is a retrospective chart review for patients diagnosed with Chronic Migraine. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | There is no intervention in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raleigh | North Carolina | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Migraine Diagnosis | This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Migraine Diagnosis | This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. |
| BG001 | Other Headache Diagnoses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All enrolled subjects | Posted | Number | Participants | 15 Months |
|
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Adverse events (AEs) and serious adverse events (SAEs) were not collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Migraine Diagnosis | This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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The number of headache days is reported at the visit with the highest number of headaches. |
| 15 Months |
| 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 |
| Number of Visits for Headache Diagnosis | The number of visits for headache diagnosis is evaluated through the study period. | 15 Months |
This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Number | Participants |
|
|
|
| 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. | All enrolled subjects | Posted | Mean | Standard Deviation | Medications | 15 Months |
|
|
|
| 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. | All enrolled subjects | Posted | Mean | 95% Confidence Interval | Headache Days | 15 Months |
|
|
|
| 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. | All enrolled subjects with data for this outcome measure | Posted | Mean | 95% Confidence Interval | Days | 15 Months |
|
|
|
| Secondary | Number of Visits for Headache Diagnosis | The number of visits for headache diagnosis is evaluated through the study period. | All enrolled subjects | Posted | Mean | Standard Deviation | Visits | 15 Months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
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.
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |