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

Migraine Disorders Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502123
• Other study ID #: GMA-CAN-NEU-0336
• Status: Completed
• Start date: July 2, 2015
• Est. completion date: January 29, 2019

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Other:
• No Intervention
No intervention was administered in this study.

Locations

Country	Name	City	State
Canada	Bayside Medical Centre	Brentwood Bay	British Columbia
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Hys Medical Centre	Edmonton	Alberta
Canada	Hamilton Headache Clinic	Hamilton	Ontario
Canada	Jeff Oyler	Kamloops	British Columbia
Canada	The Shapero Markham Headache and Pain Treatment Centre	Markham	Ontario
Canada	Pain Care Clinics	Mississauga	Ontario
Canada	Centre de traitement neurologique	Monthreal	Quebec
Canada	Clinic Greene Avenue	Montreal	Quebec
Canada	Toronto Headache & Pain Centre	North York	Ontario
Canada	Hany Demian	Oakville	Ontario
Canada	Nepean Medical Centre	Ottawa	Ontario
Canada	Dhawan Medical Corporation Medical Clinic	Vancouver	British Columbia
Canada	May Ong-Lam	Vancouver	British Columbia
Canada	Island Neurology	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire		Baseline, Final Visit (Up to 2 Years)
Secondary	Clinician's Global Impression of Change Using a 7-Point Scale		Up to 2 Years
Secondary	Healthcare Resource Utilization Before and After BOTOX® using a 9-Item Questionnaire		Baseline, Up to 2 Years
Secondary	BOTOX® Treatment Regimen for Chronic Migraine		Up to 2 Years
Secondary	Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Before and After BOTOX® Consisting of 6-Items		Baseline, Up to 2 Years
Secondary	Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire		2 Years
Secondary	Change from Baseline in Beck Depression Inventory Scale at Final Visit Using a 21-Item Questionnaire		Baseline, Final Visit (Up to 2 Years)
Secondary	Reasons Why Treatment with BOTOX® Stopped		Up to 2 Years
Secondary	Headache Assessment from Patient Diary		2 Years