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This study will prospectively assess long term heath related quality of life in chronic migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA (BOTOX®) | Patients diagnosed with chronic migraine headache treated with BOTOX® as standard of care in clinical practice. No intervention was administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No intervention was administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire | Baseline, Treatment 4 (approximately 24 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire | Baseline, Final Visit (Up to 2 Years) | |
| Clinician's Global Impression of Change Using a 7-Point Scale | Up to 2 Years | |
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Inclusion Criteria:
-Patients with chronic migraine eligible to receive treatment with onabotulinumtoxinA (BOTOX®) as standard of care.
Exclusion Criteria:
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Patients with chronic migraine treated with BOTOX® as standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Goran Davidoic | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| Hys Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38105013 | Derived | Boudreau G, Finkelstein I, Graboski C, Ong M, Christie S, Sommer K, Bhogal M, Davidovic G, Becker WJ. OnabotulinumtoxinA Improves Quality of Life in Chronic Migraine: The PREDICT Study - CORRIGENDUM. Can J Neurol Sci. 2024 Jan;51(1):149. doi: 10.1017/cjn.2023.317. Epub 2023 Dec 18. No abstract available. |
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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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| Healthcare Resource Utilization Before and After BOTOX® using a 9-Item Questionnaire |
| Baseline, Up to 2 Years |
| BOTOX® Treatment Regimen for Chronic Migraine | Up to 2 Years |
| Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Before and After BOTOX® Consisting of 6-Items | Baseline, Up to 2 Years |
| Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire | 2 Years |
| Change from Baseline in Beck Depression Inventory Scale at Final Visit Using a 21-Item Questionnaire | Baseline, Final Visit (Up to 2 Years) |
| Reasons Why Treatment with BOTOX® Stopped | Up to 2 Years |
| Headache Assessment from Patient Diary | 2 Years |
| Edmonton |
| Alberta |
| T5H 4B9 |
| Canada |
| Bayside Medical Centre | Brentwood Bay | British Columbia | V8M 1P6 | Canada |
| Jeff Oyler | Kamloops | British Columbia | V2C 5T1 | Canada |
| Dhawan Medical Corporation Medical Clinic | Vancouver | British Columbia | V5Z 4E1 | Canada |
| May Ong-Lam | Vancouver | British Columbia | V6Z 2E8 | Canada |
| Island Neurology | Victoria | British Columbia | V9B 1W3 | Canada |
| Hamilton Headache Clinic | Hamilton | Ontario | L8N 1Y2 | Canada |
| The Shapero Markham Headache and Pain Treatment Centre | Markham | Ontario | L3R 9X3 | Canada |
| Pain Care Clinics | Mississauga | Ontario | L5N 6B8 | Canada |
| Toronto Headache & Pain Centre | North York | Ontario | M3B 1X7 | Canada |
| Hany Demian | Oakville | Ontario | L6K 3Y6 | Canada |
| Nepean Medical Centre | Ottawa | Ontario | K2G 6E2 | Canada |
| Centre de traitement neurologique | Monthreal | Quebec | H2W 1T9 | Canada |
| Clinic Greene Avenue | Montreal | Quebec | H3Z 2A4 | Canada |
| D009422 | Nervous System Diseases |