Treximet Migraine Brain Imaging Research Study

Acute Migraine Clinical Trial

— TREX  

Official title:

Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01112553
• Other study ID #: 2009-P-002689
• Secondary ID: 400483
• Status: Terminated
• Phase: N/A
• First received: April 27, 2010
• Last updated: October 30, 2012
• Start date: April 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Locations

Country	Name	City	State
United States	Neuroimaging Center, McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	GlaxoSmithKline

Country where clinical trial is conducted

United States,