NCT05224349已完成不适用
Effectiveness and Safety of SMART BoNT-A Therapy With Dysport® in Patients With Post-stroke Chronic Upper Limb Spasticity in Real-life Setting.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 121
- 试验地点
- 30
- 主要终点
- Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb.
研究概览
简要总结
The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (> 6 months) focal Upper Limb Spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥18 years with the capacity to consent.
- •Subjects with a post-stroke medium to severe focal upper limb spasticity for at least 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 in the PTMG and DAS ≥2 in the PTT.
- •Cohort according to SMART guidelines. The SMART injection concept is designed to be used only in patients suffering from simple patterns ("easy to diagnose spasticity pattern") of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injection can be simplified, by recognizing common spasticity patterns and key muscles for injection, identifying those muscles by palpation, and appropriate injection points of the suggested muscles using anatomic landmarks.
- •Subjects with treatment goals as reduction of pain, reduction of muscle tone, improvement of care (hygiene/dressing) and/or improvement of passive motion.
- •Subjects with the intention to be treated with Dysport® according to the current local Summary of Product Characteristics (SmPC) (Germany) and injection according to SMART must be taken prior to the entry in the study.
- •Physiotherapy should remain unchanged within 4 weeks before study start.
排除标准
- •Patients treated with intrathecal Baclofen or BoNT-A within the last 6 months
- •If treated with oral spasticity medication, change of oral spasticity medication within the last 4 weeks
- •Patients with active hand functions or patients with treatment goals of active functions.
- •Patients with any contraindication for Dysport® according to SmPC.
- •Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern other than specified in SMART guidelines).
- •Participation in an interventional trial at the same time and/or within 3 months before baseline.
- •Diagnosed contracture/contracted muscle.
结局指标
主要结局
Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb.
时间窗: At 12 weeks to 16 weeks after injection at Visit 1
The PTT will be pre-selected from the 4 DAS domains: hygiene, dressing, limb position and pain of the upper limb at Visit 1. The extent of functional impairment in the PTT will be assessed on a four-point scale (range 0 to 3, where 0=no disability, and 3=severe disability) at each visit.
次要结局
- Change from baseline of pain assessed with Visual Analogue Scale (VAS)(At 12 weeks to 16 weeks)
- Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D)(At 12 weeks to 16 weeks)
- Incidence of Adverse Events (AEs)(Up to 32 weeks)
- Incidence of Special Situations (SS)(Up to 32 weeks)
- Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG)(At 12 weeks to 16 weeks)
研究者
研究点 (30)
Loading locations...
相似试验
已完成
不适用
ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb SpasticitySpasticityNCT02275312Ipsen110
已完成
1 期
Dysport for the Treatment of OMDOral DystoniaTardive DystoniaNCT01921270Emory University18
已完成
3 期
Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary IncontinenceOveractive BladderNCT00910845Allergan557
已完成
不适用
DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical DystoniaCervical DystoniaNCT01314365Ipsen350
进行中（未招募）
1 期
Dose Optimized BNCT for Head and Neck CancerHead and Neck CancerSquamous Cell CarcinomaNCT05883007Southern Tohoku BNCT Research Center30