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

NCT ID: NCT02502123

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-02

Study Completion Date

2019-01-29

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

No intervention was administered in this study.

Interventions

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No Intervention

No intervention was administered in this study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Goran Davidoic

Role: STUDY_DIRECTOR

Allergan

Locations

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Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

Hys Medical Centre

Edmonton, Alberta, Canada

Site Status

Bayside Medical Centre

Brentwood Bay, British Columbia, Canada

Site Status

Jeff Oyler

Kamloops, British Columbia, Canada

Site Status

Dhawan Medical Corporation Medical Clinic

Vancouver, British Columbia, Canada

Site Status

May Ong-Lam

Vancouver, British Columbia, Canada

Site Status

Island Neurology

Victoria, British Columbia, Canada

Site Status

Hamilton Headache Clinic

Hamilton, Ontario, Canada

Site Status

The Shapero Markham Headache and Pain Treatment Centre

Markham, Ontario, Canada

Site Status

Pain Care Clinics

Mississauga, Ontario, Canada

Site Status

Toronto Headache & Pain Centre

North York, Ontario, Canada

Site Status

Hany Demian

Oakville, Ontario, Canada

Site Status

Nepean Medical Centre

Ottawa, Ontario, Canada

Site Status

Centre de traitement neurologique

Monthreal, Quebec, Canada

Site Status

Clinic Greene Avenue

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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GMA-CAN-NEU-0336

Identifier Type: -

Identifier Source: org_study_id

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