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Treximet Migraine Brain Imaging Research Study

NCT01112553 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2012-11-01

No results posted yet for this study

Summary

We are looking for volunteers who suffer from acute migraine (\<14 episodes per month) to participate in a 2-visit brain imaging research study. The goal of the study is to observe the effect of acute administration of Treximet during a migraine episode on the pain pathways of the migraine brain. Visit 1 will consist of 1 hour, where participants will be signing the informed consent form, completing questionnaires, meeting with the study physician, and having QST (sensory testing to determine individual pain thresholds to a heat stimulus) performed. Visit 2 will occur during a migraine episode. Volunteers will be asked to contact the study team at the first onset of a migraine. Upon arrival at Visit 2, individuals will be given an IV for blood draws. Once these the IV is in place, subjects will enter the MRI and be asked to stay very still. Scanning will occur for about 20 minutes, and then subjects will be given a Treximet tablet to combat their migraine. More scanning will follow Treximet administration. Some scans will have no stimulation, and others will apply a heat stimulus that subjects will rate using a pain scale. Seven 5-mL blood samples will be drawn throughout the duration of the MRI session. Both Visit 1 and Visit 2 will be compensated.

Conditions

  • Acute Migraine

Sponsors & Collaborators

Principal Investigators

  • David Borsook, MD, PhD · Mclean Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01112553 on ClinicalTrials.gov