Evaluation of Brain Activation in Complete Responders and Partial Responders Following Acute Administration of Treximet (Sumatriptan and Naproxen)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
David Borsook, MD, PhD
Senior Research Associate
Mclean Hospital
