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This is a population internet-based study to characterize migraine clinical course and impact on family.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Migraines | Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Treatment | Other | No Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) | EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month. | Baseline |
| Migraine Disability Assessment (MIDAS) | The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with migraine
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36701797 | Derived | Buse DC, Nahas SJ, Stewart WBF, Armand CE, Reed ML, Fanning KM, Manack Adams A, Lipton RB. Optimized Acute Treatment of Migraine Is Associated With Greater Productivity in People With Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. J Occup Environ Med. 2023 Apr 1;65(4):e261-e268. doi: 10.1097/JOM.0000000000002801. Epub 2023 Jan 25. | |
| 34476122 |
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This study was an internet survey to identify participants with Episodic Migraine (EM) and Chronic Migraine (CM). The participants were followed for up to 1 year by assessments every 3 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Migraines | Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Migraines | Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study. |
| 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 | Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) | EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month. | All qualified participants at Baseline who returned completed survey with positive screening for migraines. | Posted | Number | percentage of participants | Baseline |
|
|
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No Adverse Event data was 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 | Participants With Migraines | Participants who returned completed internet survey with positive screening for migraines. No intervention was administered 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 |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Schwedt TJ, Buse DC, Argoff CE, Reed ML, Fanning KM, Hussar CR, Adams AM, Lipton RB. Medication Overuse and Headache Burden: Results From the CaMEO Study. Neurol Clin Pract. 2021 Jun;11(3):216-226. doi: 10.1212/CPJ.0000000000001037. |
| 31690685 | Derived | Lipton RB, Fanning KM, Buse DC, Martin VT, Hohaia LB, Adams AM, Reed ML, Goadsby PJ. Migraine progression in subgroups of migraine based on comorbidities: Results of the CaMEO Study. Neurology. 2019 Dec 10;93(24):e2224-e2236. doi: 10.1212/WNL.0000000000008589. Epub 2019 Nov 5. |
| 31407321 | Derived | Buse DC, Fanning KM, Reed ML, Murray S, Dumas PK, Adams AM, Lipton RB. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019 Sep;59(8):1286-1299. doi: 10.1111/head.13613. Epub 2019 Aug 12. |
| 25304766 | Derived | Adams AM, Serrano D, Buse DC, Reed ML, Marske V, Fanning KM, Lipton RB. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015 Jun;35(7):563-78. doi: 10.1177/0333102414552532. Epub 2014 Oct 10. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Migraine Disability Assessment (MIDAS) | The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged. | All qualified participants at Baseline who returned completed survey with positive screening for migraines. | Posted | Mean | Standard Deviation | days | 12 Months |
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| 0 |
| 0 |
| 0 |
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| D009422 | Nervous System Diseases |