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

Completed

• Conditions: Migraine Disorders
• Interventions: Other: No Intervention

• Registration Number: NCT02502123
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-02
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Primary Completion: 2019-01-29
• Study Completion: 2019-01-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OnabotulinumtoxinA (BOTOX®)	No Intervention	Patients diagnosed with chronic migraine headache treated with BOTOX® as standard of care in clinical practice. No intervention was administered in this study.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Headache Assessment from Patient Diary	2 Years
Clinician's Global Impression of Change Using a 7-Point Scale	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
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
Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire	Baseline, Final Visit (Up to 2 Years)
Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire	2 Years
Reasons Why Treatment with BOTOX® Stopped	Up to 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)

Trial Locations

Locations (15)

Toronto Headache & Pain Centre; 🇨🇦 North York, Ontario, Canada

Hany Demian; 🇨🇦 Oakville, Ontario, Canada

The Shapero Markham Headache and Pain Treatment Centre; 🇨🇦 Markham, Ontario, Canada

Jeff Oyler; 🇨🇦 Kamloops, British Columbia, Canada

Hamilton Headache Clinic; 🇨🇦 Hamilton, Ontario, Canada

Island Neurology; 🇨🇦 Victoria, British Columbia, Canada

Nepean Medical Centre; 🇨🇦 Ottawa, Ontario, Canada

Centre de traitement neurologique; 🇨🇦 Monthreal, Quebec, Canada

Pain Care Clinics; 🇨🇦 Mississauga, Ontario, Canada

Bayside Medical Centre; 🇨🇦 Brentwood Bay, British Columbia, Canada

Hys Medical Centre; 🇨🇦 Edmonton, Alberta, Canada

Clinic Greene Avenue; 🇨🇦 Montreal, Quebec, Canada

May Ong-Lam; 🇨🇦 Vancouver, British Columbia, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Dhawan Medical Corporation Medical Clinic; 🇨🇦 Vancouver, British Columbia, Canada