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OpenTrials
Completed

NCT Number: NCT00754611

The Evolution and Management of Migraine Recurrence Beyond 24 Hours

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?

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Medicine and Dentistry of New Jersey

Stratford, New Jersey, 08084, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rowan University

Other

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 18, 2008
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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