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NCT00754611 Clinical Trial

The Evolution and Management of Migraine Recurrence Beyond 24 Hours

Migraine Clinical Trial

Official title:
The Evolution and Management of Migraine Recurrence Beyond 24 Hours: A Prospective Study of Tertiary Care Center Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00754611
Other study ID # EN4162008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2008
Est. completion date December 2010

Study information
Verified date October 2019
Source Rowan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Medicine and Dentistry of New Jersey Stratford New Jersey

Sponsors (2)
Lead Sponsor Collaborator
Rowan University Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Pain response and pain free data 30 minutes, 1,2,4,24,48,and 72 hours
Secondary Rate of recurrence, time of recurrence, time to re-dosing 72 hours
Secondary Rate of recurrence among multiple attacks per subject 72 hours
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