An Open-Label, Non-Inferiority Study Evaluating the Efficacy and Safety of Two Injection Schedules of Xeomin® (incobotulinumtoxinA) [Short Flex Versus Long Flex] in Subjects With Cervical Dystonia With < 10 Weeks of Benefit From OnabotulinumtoxinA Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 84
- 主要终点
- Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection
研究概览
简要总结
This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.
详细描述
Dystonia is a movement disorder which is characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures of the trunk, neck, face, or arms and legs. In focal dystonia, the abnormal movements involve a single area of the body. A commonly described form of focal dystonia is cervical dystonia (CD). Botulinum toxin treatment can be offered as a treatment option for the treatment of CD.
The current practice for botulinum toxin injection treatment is to inject patients every 3 months. However, not all patients receive continuing benefit from botulinum toxin injections for an entire 3 months. In a recent survey, approximately 45% of patients report that they would prefer a treatment cycle of less than 10 weeks.This study will compare Xeomin®, a botulinum toxin treatment, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of CD. The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.
The purpose of this research study is to evaluate the efficacy of the Short Flex dosing of Xeomin® compared to the Long Flex dosing regimen of Xeomin®, using a standard scale completed by the doctors and subjects as well as questionnaires that ask subjects to rate symptoms of CD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia
排除标准
- •Current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.
结局指标
主要结局
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection
时间窗: Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)
The validated assessment scale TWSTRS was used to measure the impact of cervical dystonia (CD) on participants. A blinded rater performed all TWSTRS-Severity subscale assessments for a given participant. TWSTRS-Severity subscale score ranges from 0 (=absence of severity) to 35 points (=maximum severity).
次要结局
- Change From Baseline in TWSTRS Disability Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection(Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Baseline in TWSTRS Pain Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection(Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Time to Offset of Xeomin Effects by Injection Cycle(Week 4 up to Week 112)
- Change From Baseline in TWSTRS Total Score Based on Unblinded Rater Assessment at Week 4 After the 8th Injection(Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Baseline in TWSTRS Severity Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection(Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Baseline in TWSTRS Total Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection(Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Control Visit Week 4 After First Injection in Subject-Rated Global Response at Week 4 After the 8th Injection(Week 4 and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Baseline in Clinical Global Impression-Severity(Baseline and 8th injection (Week 44 for Short Flex and Week 84 for Long Flex))
- Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4 After the 8th Injection(Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Control Visit Week 4 After First Injection in Investigator-Rated Global Response at Week 4 After the 8th Injection(Week 4 and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Control Visit Week 4 After First Injection in Subject Satisfaction Score at Week 4 After the 8th Injection(Week 4 and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))
- Change From Baseline in CDIP-58 Subscales' Scores at Week 4 After the 8th Injection(Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex))