Treximet Migraine Brain Imaging Research Study

Stopped early

Conditions studied: Acute Migraine

In brief

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.

Key facts

Study ID: NCT01112553
Run by: Mclean Hospital
People needed: 2
Starts: 2010-04-01
Expected to finish: 2012-10-01
Last updated by the study team: 2012-11-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female (not pregnant or nursing)
Age 18-65; with a focus on age 30-40 years
Episodic migraine (experience migraine headache <14 days out of the month), with focus on left-sided pain
Currently taking Treximet routinely for migraine treatment
No significant medical history (No illnesses such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc.)
No significant medication history, except for migraine
Weight, <285 pounds
Not claustrophobic
No contraindication to taking triptans

You may not qualify if…

Age <18 or > 65
Significant medical problems (aside from pain before, during and after migraine episodes)
Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.)
Use of opioid medications
Claustrophobia
History of dermatological hypersensitivity in the facial area
Pregnancy
Sensory loss detected on Quantitative Sensory Testing at screening
Significant alcohol history (ingestion of 5 or more glasses (> 40 oz) of alcohol per week)
Metal implants of any type (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, etc.)
Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could become heated up in the scanner, and potentially cause blistering or burning)
Cardiac pacemakers
Aneurysm clips and other vascular stents, filters, clips or other devices
Prosthetic heart valves
Other prostheses
Neuro-stimulator devices
Implanted infusion pumps
Cochlear (ear) implants
Ocular (eye) implants or known metal fragments in eyes
Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
Other metallic surgical hardware in vital areas
Any known allergic side effects to Treximet
Use of any of the following medications:
Monoamine Oxidase A- Inhibitors (Azilect, Eldepryl, Marplan, Nardil, Parnate, Zelapar)
SSRI's: citalopram/ Celexa, Lepraxo, paroxetine/ Paxil, fluoxetine/ Prozac, Sarafem, Symbyax, Sertraline/ Zoloft, Fluvoxamine/ Luvox

Where it is running

Neuroimaging Center, McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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