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Treximet Migraine Brain Imaging Research Study (TREX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112553
Recruitment Status : Terminated (Study was closed due to low enrollment numbers.)
First Posted : April 28, 2010
Last Update Posted : November 1, 2012
Information provided by (Responsible Party):
David Borsook, MD, PhD, Mclean Hospital

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.

Condition or disease
Acute Migraine

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Official Title: Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)
Study Start Date : April 2010
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

All migraine subjects will receive Treximet during a migraine episode at Visit 2.

Biospecimen Retention:   Samples With DNA
Seven 5-mL blood samples will be drawn throughout the MRI session, and blood plasma will be analyzed for the concentration of Treximet.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112553

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United States, Massachusetts
Neuroimaging Center, McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
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Principal Investigator: David Borsook, MD, PhD Mclean Hospital

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Responsible Party: David Borsook, MD, PhD, Senior Research Associate, Mclean Hospital Identifier: NCT01112553     History of Changes
Other Study ID Numbers: 2009-P-002689
400483 ( Other Grant/Funding Number: GlaxoSmithKline )
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by David Borsook, MD, PhD, Mclean Hospital:
Acute Migraine
Heat Stimulus

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents