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

Conditions

Migraine Disorders

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.

Corrie Graboski, May Ong-Lam, Werner J. Becker, Julia Ma, Katherine Sommer et al. (7 authors)

2023-08-01

10.1136/bmjno-2023-anzan.49

P.021 Evaluation of PREEMPT fixed-dose, fixed-site and follow the pain treatment paradigms in the PREDICT Study

C Graboski, M Ong-Lam, Wolfgang Alexander Becker, G Boudreau, G Davidovic et al. (8 authors)

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques2022-06-01

10.1017/cjn.2022.124

OnabotulinumtoxinA Treatment Improved Health-Related Quality of Life in Adults with Chronic Migraine: Results from a Prospective, Observational Study (PREDICT) (714)

Guy Boudreau, Ian Finkelstein, Corrie Graboski, May Ong, Suzanne Christie et al. (9 authors)

Neurology2020-04-141 citations

10.1212/wnl.94.15_supplement.714

P.011 OnabotulinumtoxinA, quality of life, health resource utilization, and work productivity in chronic migraine: interim results from PREDICT

Guy Boudreau, W Becker, Corrie Graboski, May Ong-Lam, Ian Finkelstein et al. (8 authors)

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques2019-06-01

10.1017/cjn.2019.112

Impact of OnabotulinumtoxinA on Quality of Life, Health Resource Utilization, and Work Productivity in People With Chronic Migraine: Interim Results From a Prospective, Observational Study (PREDICT) (P4.10-023)

Guy Boudreau, Werner J. Becker, Corrie Graboski, May Ong-Lam, Ian Finkelstein et al. (8 authors)

Neurology2019-04-094 citations

10.1212/wnl.92.15_supplement.p4.10-023

Interventions

OTHERNo Intervention

No intervention was administered in this study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

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

Measure	Time frame
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
Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire	Baseline, Final Visit (Up to 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
Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire	2 Years

Countries

Canada

Outcome results

None listed