Patient Reported Outcomes in Patients With Chronic Migraine Treated With BOTOX® (PREDICT)

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

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 Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Edmonton, Alberta, Canada, T5H 4B9
      • Hys Medical Centre
  • British Columbia
    • Brentwood Bay, British Columbia, Canada, V8M 1P6
      • Bayside Medical Centre
    • Kamloops, British Columbia, Canada, V2C 5T1
      • Jeff Oyler
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Dhawan Medical Corporation Medical Clinic
    • Vancouver, British Columbia, Canada, V6Z 2E8
      • May Ong-Lam
    • Victoria, British Columbia, Canada, V9B 1W3
      • Island Neurology
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Hamilton Headache Clinic
    • Markham, Ontario, Canada, L3R 9X3
      • The Shapero Markham Headache and Pain Treatment Centre
    • Mississauga, Ontario, Canada, L5N 6B8
      • Pain Care Clinics
    • North York, Ontario, Canada, M3B 1X7
      • Toronto Headache & Pain Centre
    • Oakville, Ontario, Canada, L6K 3Y6
      • Hany Demian
    • Ottawa, Ontario, Canada, K2G 6E2
      • Nepean Medical Centre
  • Quebec
    • Monthreal, Quebec, Canada, H2W 1T9
      • Centre de traitement neurologique
    • Montreal, Quebec, Canada, H3Z 2A4
      • Clinic Greene Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with chronic migraine treated with BOTOX® as standard of care.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Intervention; No intervention was administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Goran Davidoic, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2015
• Primary Completion (Actual): January 29, 2019
• Study Completion (Actual): January 29, 2019

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: GMA-CAN-NEU-0336