Clinical trial NCT02502123: Patient Reported Outcomes in Patients With Chronic Migraine Treated With BOTOX®
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic migraine treated with BOTOX® as standard of care.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire
timeFrame: Baseline, Treatment 4 (approximately 24 Weeks)
Secondary outcomes:
measure: Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire
timeFrame: Baseline, Final Visit (Up to 2 Years)
measure: Clinician's Global Impression of Change Using a 7-Point Scale
timeFrame: Up to 2 Years
measure: Healthcare Resource Utilization Before and After BOTOX® using a 9-Item Questionnaire
timeFrame: Baseline, Up to 2 Years
measure: BOTOX® Treatment Regimen for Chronic Migraine
timeFrame: Up to 2 Years
measure: Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Before and After BOTOX® Consisting of 6-Items
timeFrame: Baseline, Up to 2 Years
measure: Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire
timeFrame: 2 Years
measure: Change from Baseline in Beck Depression Inventory Scale at Final Visit Using a 21-Item Questionnaire
timeFrame: Baseline, Final Visit (Up to 2 Years)
measure: Reasons Why Treatment with BOTOX® Stopped
timeFrame: Up to 2 Years
measure: Headache Assessment from Patient Diary
timeFrame: 2 Years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Hys Medical Centre
state: Alberta
city: Brentwood Bay
country: Canada
facility: Bayside Medical Centre
state: British Columbia
city: Kamloops
country: Canada
facility: Jeff Oyler
state: British Columbia
city: Vancouver
country: Canada
facility: Dhawan Medical Corporation Medical Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: May Ong-Lam
state: British Columbia
city: Victoria
country: Canada
facility: Island Neurology
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Headache Clinic
state: Ontario
city: Markham
country: Canada
facility: The Shapero Markham Headache and Pain Treatment Centre
state: Ontario
city: Mississauga
country: Canada
facility: Pain Care Clinics
state: Ontario
city: North York
country: Canada
facility: Toronto Headache & Pain Centre
state: Ontario
city: Oakville
country: Canada
facility: Hany Demian
state: Ontario
city: Ottawa
country: Canada
facility: Nepean Medical Centre
state: Ontario
city: Monthreal
country: Canada
facility: Centre de traitement neurologique
state: Quebec
city: Montreal
country: Canada
facility: Clinic Greene Avenue
state: Quebec
Study officials:
affiliation: Allergan
name: Goran Davidoic
role: STUDY_DIRECTOR
References: