NCT00541905已完成4 期
Prospective, Single-arm, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 and the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Patients With Cervical Dystonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4
研究概览
简要总结
The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - total score at baseline > / = 25 with TWSTRS - severity score > / = 10 and TWSTRS - disability score > / = 3
- •Patients must be on a stable dose of other medications
- •For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry
- •For pre-treated patients only: At least 10 weeks must have passed between the last injection session of botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit.
- •For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of Botox® or Xeomin®, or ≤ 1,200 units Dysport®.
- •Age > / = 18 and < 76 years
排除标准
- 未提供
研究组 & 干预措施
NT 201 (50-300 Units)
Experimental
NT 201 (Xeomin®, also know as IncobotulinumtoxinA or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
干预措施: NT 201 (Drug)
结局指标
主要结局
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4
时间窗: From baseline to week 4
次要结局
- Duration of treatment effect(Up to 24 weeks from last injection session)
- Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline(From study baseline up to week 100)
- TWSTRS, overall interventional effect(From study baseline to week 14-28, 24-52, 34-76, and 44-100)
- Subject Evaluation of Global Response (PEGR)(Week 10-24, 20-48, 30-72, and 40-96)
- TWSTRS, Single interventional effect(From week 10-24 to week 14-28, from week 20-48 to week 24-52, from week 30-72 to week 34-76, and from week 40-96 to week 44-100)
- Global Assessment of Efficacy by Investigator (GAEI)(Week 10-24, 20-48, 30-72, and 40-96)
- Time from last injection session to onset of treatment effect as given by subjective subject assessment(Up to 4 weeks from last injection session)
- Time from last injection session to waning of treatment effect as rated by subjective subject assessment(Up to 24 weeks from last injection session)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial LinesModerate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)NCT04622254Merz North America, Inc.368
已完成
3 期
Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial LinesModerate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)NCT04594213Merz North America, Inc.362
已完成
2 期
A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the ArmEssential Tremor of the Upper LimbNCT04766723Merz Pharmaceuticals GmbH78
已完成
3 期
IncobotulinumtoxinA (Xeomin) for Upper Limb SpasticityUpper Limb SpasticityNCT00465738Merz Pharmaceuticals GmbH216
已完成
3 期
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown LinesModerate to Severe Glabellar Frown LinesNCT00770211Merz Pharmaceuticals GmbH271