EUCTR2011-001952-12-ES进行中（未招募）1 期
Estudio abierto para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de AFQ056 en pacientes adultos con síndrome X frágil
ovartis Farmacéutica S.A0 个研究点目标入组 148 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
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
- •- Must have been enrolled in Studies CAFQ056A2204 or CAFQ056A2212
- •- Has a caregiver who spends, on average, at least 6 hours per day with
- •the patient , who is willing to and capable of supervising treatment,
- •providing input into efficacy and safety assessments, and accompanying
- •the patient to study visits.
- •Other protocol-defined inclusion criteria may apply
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any advanced, severe or unstable disease
- •- History of severe self-injurious behavior
- •- History of uncontrolled seizure disorder or resistant to therapy within
- •the past 2 years (Patients who are clinically stable under anti-convulsant
- •therapy for the past 2 years are not excluded)
- •- History of clinically significant allergies requiring hospitalization or
- •non-inhaled corticosteroid therapy (asthma, anaphylaxis, etc.)
- •- Any treatment regimen, including psychotropic and/or anticonvulsant
- •therapy that has not been stable for ? 6 weeks prior to randomization
- •- Current treatment with more than two psychoactive medications,
- •excluding medication used specifically for seizure control
- •- Using (or used within 6 weeks before randomization) concomitant
- •medications that are potent inhibitors or inducers of CYP3A4
- •- Using glutamatergic agents (riluzole, memantine, etc.) or lithium
- •within 6 weeks of randomization
- •- Planning to initiate or change pharmacologic or non-pharmacologic
- •interventions during the course of the study
- •Other protocol-defined exclusion criteria may apply
研究者
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