Clinical trial NCT01112553: Treximet Migraine Brain Imaging Research Study
Official title: Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Migraine
Keywords: Acute Migraine
Treximet
Imaging
fMRI
Pain
Heat Stimulus
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-04-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* SNRI's: duloxetine/ Cymbalta, venlafaxine/ Effexor
* Triptans: sumatriptan/ Imitrex, naratriptan/ Amerge, zolmitriptan/ Zomig, rizatriptan/ Maxalt, eletriptan/ Relpax, almotriptan/ Axert
* Ergotamine type medicines: Bellergal, Cafergot, Ergomar, Wiraine, Migranal/ DHE45, Sansert

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: Neuroimaging Center, McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: David Borsook, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: