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Completed

NCT Number: NCT02502123

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

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention was administered in this study.

Primary outcomes

  1. 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

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

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

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

    Time frame: Up to 2 Years

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

    Time frame: Baseline, Up to 2 Years

  4. BOTOX® Treatment Regimen for Chronic Migraine

    Time frame: Up to 2 Years

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

    Time frame: Baseline, Up to 2 Years

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

    Time frame: 2 Years

  7. 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)

  8. Reasons Why Treatment with BOTOX® Stopped

    Time frame: Up to 2 Years

  9. Headache Assessment from Patient Diary

    Time frame: 2 Years

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Acronym: PREDICT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2015
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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