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The Evolution and Management of Migraine Recurrence Beyond 24 Hours

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ClinicalTrials.gov Identifier: NCT00754611
Recruitment Status : Unknown
Verified February 2010 by Rutgers, The State University of New Jersey.
Recruitment status was:  Active, not recruiting
First Posted : September 18, 2008
Last Update Posted : February 4, 2010
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by:
Rutgers, The State University of New Jersey

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?

Condition or disease
Migraine

Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : December 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources




Primary Outcome Measures :
  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) [ Time Frame: 4 to 72 hours ]

Secondary Outcome Measures :
  1. Pain response and pain free data [ Time Frame: 30 minutes, 1,2,4,24,48,and 72 hours ]
  2. Rate of recurrence, time of recurrence, time to re-dosing [ Time Frame: 72 hours ]
  3. Rate of recurrence among multiple attacks per subject [ Time Frame: 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

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