This trial is active, not recruiting.

Condition migraine
Sponsor University of Medicine and Dentistry of New Jersey
Collaborator Endo Pharmaceuticals
Start date December 2008
End date December 2010
Trial size 100 participants
Trial identifier NCT00754611, EN4162008


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?

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

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)
time frame: 4 to 72 hours

Secondary Outcomes

Pain response and pain free data
time frame: 30 minutes, 1,2,4,24,48,and 72 hours
Rate of recurrence, time of recurrence, time to re-dosing
time frame: 72 hours
Rate of recurrence among multiple attacks per subject
time frame: 72 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Additional Information

Official title The Evolution and Management of Migraine Recurrence Beyond 24 Hours: A Prospective Study of Tertiary Care Center Patients
Principal investigator Loretta Mueller, DO
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.