Acute MigraineTREXNCT01112553
Treximet Migraine Brain Imaging Research Study
An observational study of Acute Migraine, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Migraine
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- Weight, <285 pounds
- Not claustrophobic
- No contraindication to taking triptans
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroimaging Center, McLean Hospital
Belmont, Massachusetts, 02478
About this study
Official title: Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)
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
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treximet | All migraine subjects will receive Treximet during a migraine episode at Visit 2. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Study completionOct 2012
Why it stopped: Study was closed due to low enrollment numbers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, David Borsook, MD, PhD, Mclean Hospital
- Investigators
- David Borsook, MD, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112553
- Sponsor's protocol ID
- 2009-P-002689
- Other IDs
- 400483
- Acronym
- TREX
- Status last verified
- Oct 2012
- First submitted
- 27 Apr 2010
- Last updated
- 1 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)
- ClinicalTrials.gov ID
- NCT01112553
- Acronym / sponsor ID
- TREX / 2009-P-002689
- Conditions
- Acute Migraine
- Keywords
- Acute Migraine, Treximet, Imaging, fMRI, Pain, Heat Stimulus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was closed due to low enrollment numbers.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2010
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treximet | – | –All migraine subjects will receive Treximet during a migraine episode at Visit 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.)
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study was closed due to low enrollment numbers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Borsook, MD, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Migraine, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was closed due to low enrollment numbers.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.