The Evolution and Management of Migraine Recurrence Beyond 24 Hours

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Rutgers, The State University of New Jersey.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00754611
First received: September 9, 2008
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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?


Condition
Migraine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Evolution and Management of Migraine Recurrence Beyond 24 Hours: A Prospective Study of Tertiary Care Center Patients

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain response and pain free data [ Time Frame: 30 minutes, 1,2,4,24,48,and 72 hours ] [ Designated as safety issue: No ]
  • Rate of recurrence, time of recurrence, time to re-dosing [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Rate of recurrence among multiple attacks per subject [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754611

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, United States, 08084
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Endo Pharmaceuticals
Investigators
Principal Investigator: Loretta Mueller, DO Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Loretta Mueller, D.O., University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00754611     History of Changes
Other Study ID Numbers: EN4162008
Study First Received: September 9, 2008
Last Updated: February 3, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Recurrence
Migraine Disorders
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014