BOTOX® Prophylaxis in Patients With Chronic Migraine
1 other identifier
observational
1,168
4 countries
4
Brief Summary
This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Typical duration for all trials
4 active sites
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
First Submitted
Initial submission to the registry
September 9, 2011
CompletedStudy Start
First participant enrolled
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2015
CompletedResults Posted
Study results publicly available
December 12, 2016
CompletedJanuary 8, 2019
December 1, 2018
3.7 years
September 9, 2011
July 26, 2016
December 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence Rate of Dysphagia
Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.
64 weeks
Secondary Outcomes (1)
Incidence Rate of Intractable Migraine
64 weeks
Study Arms (1)
botulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Interventions
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Eligibility Criteria
Patients with Chronic Migraine
You may qualify if:
- Diagnosis of chronic migraine
- Willing to use BOTOX® as preventative treatment for migraine
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (4)
Unknown Facility
Munich, Germany
Unknown Facility
Oviedo, Spain
Unknown Facility
Stockholm, Sweden
Unknown Facility
London, United Kingdom
Related Publications (1)
Matharu M, Pascual J, Nilsson Remahl I, Straube A, Lum A, Davar G, Odom D, Bennett L, Proctor C, Gutierrez L, Andrews E, Johannes C. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017 Dec;37(14):1384-1397. doi: 10.1177/0333102417724150. Epub 2017 Jul 31.
PMID: 28758415BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2011
First Posted
September 13, 2011
Study Start
September 9, 2011
Primary Completion
May 12, 2015
Study Completion
May 12, 2015
Last Updated
January 8, 2019
Results First Posted
December 12, 2016
Record last verified: 2018-12