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

Allergan215 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

215

Conditions

Migraine Disorders

Interventions

No InterventionOTHER

No intervention was administered in this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Foothills Medical Centre

Calgary, Alberta, Canada

Hys Medical Centre

Edmonton, Alberta, Canada

Bayside Medical Centre

Brentwood Bay, British Columbia, Canada

Outcomes

Primary Outcomes

Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire

Time frame: Baseline, Treatment 4 (approximately 24 Weeks)

Secondary Outcomes

Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire

Time frame: Baseline, Final Visit (Up to 2 Years)

Clinician's Global Impression of Change Using a 7-Point Scale

Time frame: Up to 2 Years

Healthcare Resource Utilization Before and After BOTOX® using a 9-Item Questionnaire

Time frame: Baseline, Up to 2 Years

BOTOX® Treatment Regimen for Chronic Migraine

Time frame: Up to 2 Years

Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Before and After BOTOX® Consisting of 6-Items

Time frame: Baseline, Up to 2 Years

Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire

Time frame: 2 Years

Change from Baseline in Beck Depression Inventory Scale at Final Visit Using a 21-Item Questionnaire

Time frame: Baseline, Final Visit (Up to 2 Years)

Reasons Why Treatment with BOTOX® Stopped

Time frame: Up to 2 Years

Headache Assessment from Patient Diary

Time frame: 2 Years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.