NCT02502123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

3.6 years

First QC Date

July 16, 2015

Last Update Submit

April 3, 2019

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

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

    Baseline, Final Visit (Up to 2 Years)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

No InterventionOTHER

No intervention was administered in this study.

OnabotulinumtoxinA (BOTOX®)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic migraine treated with BOTOX® as standard of care.

You may qualify if:

  • Patients with chronic migraine eligible to receive treatment with onabotulinumtoxinA (BOTOX®) as standard of care.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Hys Medical Centre

Edmonton, Alberta, T5H 4B9, Canada

Location

Bayside Medical Centre

Brentwood Bay, British Columbia, V8M 1P6, Canada

Location

Jeff Oyler

Kamloops, British Columbia, V2C 5T1, Canada

Location

Dhawan Medical Corporation Medical Clinic

Vancouver, British Columbia, V5Z 4E1, Canada

Location

May Ong-Lam

Vancouver, British Columbia, V6Z 2E8, Canada

Location

Island Neurology

Victoria, British Columbia, V9B 1W3, Canada

Location

Hamilton Headache Clinic

Hamilton, Ontario, L8N 1Y2, Canada

Location

The Shapero Markham Headache and Pain Treatment Centre

Markham, Ontario, L3R 9X3, Canada

Location

Pain Care Clinics

Mississauga, Ontario, L5N 6B8, Canada

Location

Toronto Headache & Pain Centre

North York, Ontario, M3B 1X7, Canada

Location

Hany Demian

Oakville, Ontario, L6K 3Y6, Canada

Location

Nepean Medical Centre

Ottawa, Ontario, K2G 6E2, Canada

Location

Centre de traitement neurologique

Monthreal, Quebec, H2W 1T9, Canada

Location

Clinic Greene Avenue

Montreal, Quebec, H3Z 2A4, Canada

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Goran Davidoic

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 20, 2015

Study Start

July 2, 2015

Primary Completion

January 29, 2019

Study Completion

January 29, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

CA(15)