NCT01112553

Treximet Migraine Brain Imaging Research Study

Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2010-04-01
• Completion: 2012-10-01
• First posted: 2010-04-28
• Last updated: 2012-11-01

Locations

1 site across 1 country: United States