NCT01127750
已完成
3 期
A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis
概览
- 阶段
- 3 期
- 干预措施
- FTY720
- 疾病 / 适应症
- Relapsing Multiple Sclerosis
- 发起方
- Novartis
- 入组人数
- 2417
- 试验地点
- 6
- 主要终点
- Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
研究者
入排标准
入选标准
- •18-65 years of age, must have relapsing MS
排除标准
- •Patients with a type of MS that is not relapsing
- •Patients with history of chronic immune disease
- •Patients with a history of certain cancers
- •Diabetic patients with certain eye disorders
- •Patients who are on certain immunosuppressive medications or heart medications
- •Patients with certain heart conditions
- •Patients with certain lung conditions
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
FTY720
干预措施: FTY720
结局指标
主要结局
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
时间窗: 4 months
次要结局
- Incidence of bradyarrhythmic electrocardiograms (ECGs)(4 months)
- Incidence of macular edema(4 months)
- Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)(4 months)
研究点 (6)
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