The Evolution and Management of Migraine Recurrence Beyond 24 Hours
1 other identifier
observational
100
1 country
1
Brief Summary
What is the course of migraine headache recurrence, how is it managed, what characteristics are associated with it, and how does it influence patient satisfaction with treatment?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2008
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
September 9, 2008
CompletedFirst Posted
Study publicly available on registry
September 18, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedOctober 28, 2019
October 1, 2019
2 years
September 9, 2008
October 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Primary efficacy outcomes will be sustained pain free response between 4 and 72 hours after initial abortive medication dosing (lack of recurrence over 72 hours)
4 to 72 hours
Secondary Outcomes (3)
Pain response and pain free data
30 minutes, 1,2,4,24,48,and 72 hours
Rate of recurrence, time of recurrence, time to re-dosing
72 hours
Rate of recurrence among multiple attacks per subject
72 hours
Eligibility Criteria
Patients at the University Headache Center, aged 18 or older, with a diagnosis of migraine with and/or without aura as defined by ICHD-II criteria
You may qualify if:
- Female and male patients at University Headache Center with \> 6 month diagnosis of migraine with and/or without aura (ICHD-II)
- Greater than or equal to 18 years old
You may not qualify if:
- Greater than 15 days/month total headache days
- Analgesic use greater than 15 days/month (other than aspirin less than or equal to 325mg/d)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rowan Universitylead
- Endo Pharmaceuticalscollaborator
Study Sites (1)
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, 08084, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loretta Mueller, DO
Rutgers, The State University of New Jersey
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2008
First Posted
September 18, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
October 28, 2019
Record last verified: 2019-10