A phase 2a Study of the Safety and Effectiveness of NXN-188 for the Acute Treatment of Migraine Attacks with Aura

Peer Tfelt-Hansen0 个研究点开始时间: 2009年3月10日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects must meet the following criteria for inclusion in the study:
•1.Male or female migraineurs with aura between 18 and 65 years old, inclusive
•2.Meets the following criteria for migraine headache with aura:
•Diagnosed with a history of migraine with aura
•Aura consisting of at least one of the following, but no muscle weakness or paralysis:
•oFully reversible visual symptoms (e.g. flickering lights, spots, lines, loss of vision)
•oFully reversible sensory symptoms (e.g. pins and needles, numbness)
•oFully reversible dysphasia (speech disturbance)
•Aura has at least two of the following characteristics:
•oVisual symptoms affecting just one side of the field of vision and/or sensory symptoms affecting just one side of the body
•oAt least one aura symptom develops gradually over more than 5 minutes and/or different aura symptoms occur one after the other over more than 5 minutes
•oEach symptom lasts from 5–60 minutes
•3.At least one migraine headache with aura every 8-weeks and resulting in moderate to severe pain (on a 4-point categorical scale) within 2 hours of the onset of aura.
•4.Migraine pain following aura in at least 75% of occurrences
•5.The subject has a body mass index (BMI) within the range of 18 to 32
•6.The subject is in general good health as determined by the medical history, physical exam, clinical laboratory tests, vital signs [heart rate (HR) and blood pressure (BP; after a 3-minute sitting period)] and ECG
•ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits
•7.The subject must be able to speak, read, and understand Danish sufficiently to understand the nature of the study, to provide written informed consent, and complete all study assessments
•8.The subject is willing and able to comply with all testing requirements defined in the protocol
•9.All females will avoid pregnancy at least 10 days before Visit 1, during the study and up until 3 months after Visit 2
•10.Women of childbearing potential must be using a reliable form of contraception. A reliable form of contraception is defined as follows:
•sterilisation (via hysterectomy or bilateral tubal ligation)
•sterilisation of partner
•birth control pills on stable dose for at least three months before Visit 1, and one month after visit 2.
•medroxyprogesterone acetate (Depo-Provera) or etonogestrel (implanom) active for at least three months prior to the study and with continued administration at intervals sufficient to maintain contraceptive efficacy throughout the study period and at least one month after visit 2.Males must use condoms as contraception.
•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) no
•F.1.3.1 Number of subjects for this age range

排除标准

•4.2.2Exclusion Criteria
•Subjects meeting any of the following criteria will be excluded:
•1.Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator
•2.Are pregnant or lactating
•3.History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease
•4.Receiving any medication that, in the opinion of the Investigator or designee, may pose a risk of compromising tolerance or compliance
•5.Are known to or suspected to be currently abusing alcohol or drugs, or have a history (within the past 12 months) of active alcohol or drug abuse
•6.Participation in another drug or biologic study within 30 days preceding randomization into this study or during participation in this study
•7.Subjects who are unable or unwilling, in the opinion of the Investigator, to comply with all study procedures and cooperate fully with study center staff

研究者

发起方

Peer Tfelt-Hansen

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