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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02502123
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : April 5, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Migraine Disorders Other: No Intervention

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Study Type : Observational
Actual Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : July 2, 2015
Actual Primary Completion Date : January 29, 2019
Actual Study Completion Date : January 29, 2019

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic migraine treated with BOTOX® as standard of care.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502123

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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Hys Medical Centre
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Bayside Medical Centre
Brentwood Bay, British Columbia, Canada, V8M 1P6
Jeff Oyler
Kamloops, British Columbia, Canada, V2C 5T1
Dhawan Medical Corporation Medical Clinic
Vancouver, British Columbia, Canada, V5Z 4E1
May Ong-Lam
Vancouver, British Columbia, Canada, V6Z 2E8
Island Neurology
Victoria, British Columbia, Canada, V9B 1W3
Canada, Ontario
Hamilton Headache Clinic
Hamilton, Ontario, Canada, L8N 1Y2
The Shapero Markham Headache and Pain Treatment Centre
Markham, Ontario, Canada, L3R 9X3
Pain Care Clinics
Mississauga, Ontario, Canada, L5N 6B8
Toronto Headache & Pain Centre
North York, Ontario, Canada, M3B 1X7
Hany Demian
Oakville, Ontario, Canada, L6K 3Y6
Nepean Medical Centre
Ottawa, Ontario, Canada, K2G 6E2
Canada, Quebec
Centre de traitement neurologique
Monthreal, Quebec, Canada, H2W 1T9
Clinic Greene Avenue
Montreal, Quebec, Canada, H3Z 2A4
Sponsors and Collaborators
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Study Director: Goran Davidoic Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02502123    
Other Study ID Numbers: GMA-CAN-NEU-0336
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases