NCT01753349已完成不适用
An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact
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
- 1,050
- 试验地点
- 113
- 主要终点
- Change in subject's satisfaction using a 5-point Likert scale.
研究概览
简要总结
The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).
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
- •Subject for whom there is an intention to treat with BoNT-A.
- •BoNT treatment naïve or previously treated with BoNT.
- •If previously treated with BoNT, at least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion.
- •Subject able to comply with the protocol.
- •Provision of written informed consent prior to collect the data.
排除标准
- •Contraindications to any BoNT-A preparations.
- •The subject has already been included in the study.
结局指标
主要结局
Change in subject's satisfaction using a 5-point Likert scale.
时间窗: Baseline and at every 3 to 4 months, up to 3 years.
Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.
次要结局
- Change in tremor associated with CD using Tsui score(Baseline and at every 3 to 4 months, up to 3 years.)
- Change in disability will be measured with the TWSTRS disability sub-scale.(Baseline and at every 3 to 4 months, up to 3 years.)
- Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.(Baseline and at every 3 to 4 months, up to 3 years.)
- Change in pain relief assessed using the TWSTRS pain sub-scale.(Baseline and at every 3 to 4 months, up to 3 years.)
- Pharmaco-economic endpoints(Baseline and at every 3 to 4 months, up to 3 years.)
研究者
研究点 (113)
Loading locations...
相似试验
已完成
不适用
A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)Ankylosing Spondylitis (AS)NCT03505892AbbVie28
已完成
不适用
Observational Study of C. Diff in Post-Transplant PatientsClostridium DifficileNCT02747017University of Minnesota132
招募中
不适用
Observational Retro-prospective Study on PD1/PDL1 Inhibitors Treatment Duration in Patients With NSCLCNon-small Cell Lung CancerNCT05418660University of Milano Bicocca300
招募中
不适用
A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple MyelomaRelapsed/Refractory Multiple MyelomaNCT05160584Janssen Pharmaceutica N.V., Belgium300
进行中（未招募）
不适用
Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational StudyPrurigo NodularisNCT05991323Sanofi100