JPRN-jRCT1031230129进行中（未招募）Unknown
Safety and efficacy of step-up dose onabotulinumtoxinA in the treatment of upper and lower limb spasticity: an observational study in Japan
Ai Hayashi0 个研究点目标入组 100 人开始时间: 2023年6月12日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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 至 ot applicable（—）
- 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)
- •1.Safety outcomes: variables of AEs
- •2.Efficacy outcomes: variables of patient-reported satisfaction with onabotulinumtoxinA, and physician-reported satisfaction with onabotulinumtoxinA
- •3.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
研究者
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