Patient Reported Outcomes in Patients With Chronic Migraine Treated With BOTOX®

Study Overview
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Brief Summary
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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.

Official Title
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Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Chronic Migraine and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (PREDICT)

Conditions
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Migraine Disorders

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients with chronic migraine eligible to receive treatment with onabotulinumtoxinA (BOTOX®) as standard of care. Exclusion Criteria: Diagnosis of hemiplegic migraine, basilar migraine, ophthalmoplegic migraine or migrainous infarction, chronic tension-type headache, hypnic headache, hemicrania continua or new daily persistent headache. Patient who is currently taking or planning on taking opioid-containing products, barbiturates or combination for acute headache or pain condition. Treatment with any other botulinum toxin product for any condition within 3 months of the screening visit. Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OnabotulinumtoxinA (BOTOX®)<br>Patients diagnosed with chronic migraine headache treated with BOTOX® as standard of care in clinical practice. No intervention was administered in this study. | Other: No Intervention<br>* No intervention was administered in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |