Treximet Migraine Brain Imaging Research Study (TREX)

This study has been terminated.
(Study was closed due to low enrollment numbers.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
David Borsook, MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01112553
First received: April 27, 2010
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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
Acute Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

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.


Enrollment: 2
Study Start Date: April 2010
Study Completion Date: October 2012
Groups/Cohorts
Treximet
All migraine subjects will receive Treximet during a migraine episode at Visit 2.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112553

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

No publications provided

Responsible Party: David Borsook, MD, PhD, Senior Research Associate, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01112553     History of Changes
Other Study ID Numbers: 2009-P-002689, 400483
Study First Received: April 27, 2010
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Acute Migraine
Treximet
Imaging
fMRI
Pain
Heat Stimulus

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014