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| ID | Type | Description | Link |
|---|---|---|---|
| 400483 | Other Grant/Funding Number | GlaxoSmithKline |
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Study was closed due to low enrollment numbers.
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treximet | All migraine subjects will receive Treximet during a migraine episode at Visit 2. |
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Inclusion Criteria:
Exclusion Criteria:
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English-speaking males or females between the ages of 18 and 65, who suffer from acute migraine (<14 migraine episodes/ month), will be recruited for this study.
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| Name | Affiliation | Role |
|---|---|---|
| David Borsook, MD, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroimaging Center, McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Seven 5-mL blood samples will be drawn throughout the MRI session, and blood plasma will be analyzed for the concentration of Treximet.