NCT01114711终止不适用
Mapping CNS Changes to Frovatriptan Administration in Acute Treatment of Prodrome or Preventative Treatment of Menstrual Migraine (MM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
We are looking for women who suffer from menstrual migraine to participate in a 2-visit migraine brain imaging research study. Our goal is to see how the menstrual migraine brain's pain pathways function when the migraineur has been taking Frovatriptan. During the screening visit (Visit 1) participants will sign the informed consent form, complete questionnaires, meet with the study physician, and have QST (quantitative sensory testing: to determine your pain thresholds for a heat stimulus) performed. For Visit 2's MRI scan, subjects will be asked to lie very still while the scan is occurring. In some parts, they will not have to do anything, while in others they will be asked to rate pain and unpleasantness for brush and thermal stimuli. Participants are compensated for both visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Regular Menstrual Phase
- •Menstrual Migraine
- •No significant medical history (Significant medical history of 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
- •All patients will be currently taking or have previously taken triptan medications for migraine
- •Weight, <285 pounds
- •Not claustrophobic
- •No contraindication to taking triptans
排除标准
- •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.)
- •Positive alcohol screen
- •Women taking oral contraceptives
- •Claustrophobia
- •History of dermatological hypersensitivity in the facial area
- •Positive history of cardiac problems/ abnormalities seen in EKG at initial screening visit
- •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
- •Use of any of the following medications:
- •Propanolol/ Inderol
- •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
- •ketoconazole (Nizoral, Fungoral)
- •itraconazole (Sporanox)
- •ritonavir (Norvir)
- •erythromycin (Erythrocin)
研究者
David Borsook, MD, PhD
Director, Pain and Analgesia Imaging Group
Mclean Hospital
研究点 (1)
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