The Evolution and Management of Migraine Recurrence Beyond 24 Hours

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

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?

Study Overview

• Status: Completed
• Conditions: Migraine

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Stratford, New Jersey, United States, 08084
      • University of Medicine and Dentistry of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rowan University
• Collaborators: Endo Pharmaceuticals
• Investigators: Principal Investigator: Loretta Mueller, DO, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 9, 2008
• First Submitted That Met QC Criteria: September 16, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Headache Disorders, Primary; Headache Disorders; Recurrence; Migraine Disorders
• Other Study ID Numbers: EN4162008