EUCTR2011-001952-12-IT进行中（未招募）不适用
An open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult patients with Fragile X Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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: 0
- •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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