A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines
1 other identifier
observational
33
1 country
1
Brief Summary
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2012
CompletedFirst Posted
Study publicly available on registry
December 13, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
September 10, 2015
CompletedSeptember 10, 2015
August 1, 2015
1 year
December 12, 2012
August 10, 2015
August 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Number of Headache Days
The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.
Treatment Cycle 7 (approximately 1.5 years)
Study Arms (1)
All participants
Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
Interventions
Previous treatment with onabotulinumtoxinA for Chronic Migraine.
Eligibility Criteria
Participants who previously received at least 7 treatment cycles of onabotulinumtoxinA as Treatment for Chronic Migraine.
You may qualify if:
- or more headache days over a 30 day period
- A minimum of 7 treatment cycles with onabotulinumtoxinA
You may not qualify if:
- Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Encinitas, California, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- 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
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2012
First Posted
December 13, 2012
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
September 10, 2015
Results First Posted
September 10, 2015
Record last verified: 2015-08