Treximet Migraine Brain Imaging Research Study

NCT01112553 | Terminated

• 2 other identifiers: 2009-P-002689400483
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Migraine

Keywords

Acute Migraine; Treximet; Imaging; fMRI; Pain; Heat Stimulus

Study Arms (1)

Treximet

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Mclean Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Neuroimaging Center, McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Borsook, MD, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: April 1, 2010
• Study Completion: October 1, 2012
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

US (1)