EUCTR2008-008283-26-IT进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial toEvaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment ofAcute Migraine in Patients on Topiramate for Migraine Prophylaxis - MK0462-085-00
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female at least 18 years of age.
- •Patient has a history of migraine with or without aura > 1 year with ≥2 and ≤8 moderate or severe migraine
- •attacks per month in the 3 months prior to screening.
- •Patient is currently taking topiratmate for migraine prophylaxis, at a minimum daily dose of 50 mg and where
- •the prescribed dose has been stable for at least 3 months.
- •Female patients of reproductive potential must agree to use acceptable method of birth control.
- •Patient understands study procedures, alternative treatments available, and risks involved with the study, and
- •voluntarily agrees to participate by giving written informed consent.
- •Patient is able to complete the study questionnaire(s) and paper diaries.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient is pregnant, or breast-feeding, or is a female expecting to conceive within the projected duration of the
- •Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in
- •less than 2 hours.
- •Patient was > 50 years old at age of migraine onset.
- •Aside from topiramate, patient is taking more than one other medication for migraine prophylaxis.
- •Patient has a history or clinical evidence of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
- •ischemic heart disease, or other significant underlying cardiovascular disease or peripheral vascular disease.
- •Patient has uncontrolled hypertension as determined by the investigator.
- •Patient is taking or has been newly prescribed selective serotonin reuptake inhibitors (SSRI) or serotonin
- •norepinephrine reuptake inhibitors (SNRI) where the prescribed daily dose has changed during the 3 months
- •prior to screening.
- •Patient is taking other migraine prophylactic medication where the prescribed daily dose has changed during the
- •3 months prior to screening.
- •Patient has either demonstrated a hypersensitivity reaction, anaphylaxis or anaphylactoid reaction to or
- •experienced a serious adverse event in response to rizatriptan.
- •Patient has a history of hypersensitivity to more than two chemical classes of drugs, including prescriptions and
- •over-the-counter medications.
- •Patient has taken any of the following medications in the time frame specified: (1) Non-steroidal antiinflammatory
- •drugs (NSAIDS), COX-2 inhibitors, or other analgesics daily or nearly daily (typically >3 days out of 7 days average); (2) Monoamine oxidase inhibitors (MAOIs) or Propranolol within 1 month prior to screening
- •and during the study. (Note: Aspirin ≤ 325 mg daily is allowed for cardioprotection.)
- •Patient has a history of neoplastic disease ≤5 years.
- •Patient is legally or mentally incapacitated.
- •Patient is currently participating or has participated in a study with an investigational compound or device
- •within 30 days of screening.
- •Patient has a history (within the past 1 year) or current evidence of drug or alcohol abuse or is a `recreational
- •user` of illicit drugs or prescription medications.
研究者
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