A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 4,734
- 试验地点
- 5
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS patients with any disease subtype who are ≥18 years of age and must have been newly prescribed Fampyra but not yet started the treatment.
- •Patients who are willing and able to provide written informed consent.
排除标准
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Fampyra
Fampyra administered as prescribed in routine clinical practice.
干预措施: Fampridine (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Day 1 up to one year
次要结局
- Utilization patterns of Fampyra in Routine Clinical Practice(Day 1 up to one year)
- Effectiveness of risk minimization measures(Day 1 up to one year)
- Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)(Baseline, Months 3, 6, 9, 12)
- Change from Baseline in Physician's Clinical Global Impression of Improvement (CGI-I) of Walking Ability Assessed Whenever the Multiple Sclerosis Participant is Seen by the Neurologist(Baseline, Day 1 up to one year)