jRCT1031230129已完成不适用
Safety and efficacy of step-up dose onabotulinumtoxinA in the treatment of upper and lower limb spasticity: an observational study in Japan
GlaxoSmithKline K.K.0 个研究点目标入组 100 人开始时间: 2023年5月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- efficacy of step-up dose onabotulinumtoxinA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 15age old over 至 No limit（—）
- 性别
- All
入选标准
- •Aged 15 years or older at the time of their informed consent
- •Patients with upper and lower limb spasticity
- •Planned to receive their first step-up dose injection of onabotulinumtoxinA (> 400 to <-600 units per treatment session) at their regular clinical treatment. This includes the following groups:
- •A. Patients who will receive their first step-up dose (> 400 to <-600 units per treatment session)
- •B. Patients who have received their first step-up dose (> 400 to <-600 units per treatment session) and are waiting for their second step-up dose
- •The group (B) should meet the criteria below:
- •First step-up dose of onabotulinumtoxinA occurred after Nov 2nd, 2022
- •The treatment information of first step-up dose of onabotulinumtoxinA (e.g., dose and injection muscles) is available
- •Possible to evaluate the safety1), efficacy2), and patient background3)of the first step-up dose (e.g, availability of medical records)
- •Safety outcomes: variables of AEs
- •Efficacy outcomes: variables of patient-reported satisfaction with onabotulinumtoxinA, and physician-reported satisfaction with onabotulinumtoxinA
- •Patient background: all variables (Exception: Regarding height and weight, the measurement at second step-up dose could be substituted if no data available at baseline)
- •Willing and able to provide informed consent to participate in this study for 48 weeks
- •Having the cognitive and linguistic ability to complete the study questionnaire
排除标准
- •Patients who received 2 or more times of step-up dose onabotulinumtoxinA (> 400 to <-600 units per treatment session)
- •Having a condition or situation that would interfere significantly with the conduct of the study, as determined by the physicians/investigators
- •Actively participating, or planning to participate in any other interventional clinical study
结局指标
主要结局
efficacy of step-up dose onabotulinumtoxinA
To evaluate the efficacy of step-up dose onabotulinumtoxinA (> 400 to <-600 units per treatment session) in patients with upper and lower limb spasticity
次要结局
- treatment patterns of step-up dose onabotulinumtoxinA
- efficacy of step-up dose onabotulinumtoxinA
研究者
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