A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport® Using 2 mL Dilution In Adults With Cervical Dystonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 112
- 试验地点
- 81
- 主要终点
- TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
研究概览
简要总结
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
- •Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport® for CD
排除标准
- •Diagnosis of pure retrocollis or pure anterocollis
- •Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
- •Known hypersensitivity to BoNT or related compounds, or any component in the study drug formulation
- •Allergy to cow's milk protein
- •Myasthenia gravis, other disease of the neuromuscular junction or clinically significant, persistent neuromuscular weakness, or disease or symptoms that could interfere with the TWSTRS scoring
- •Total body weight <95 lbs (43.09 kg)
- •Previous phenol injections to the neck muscles
- •Previous myotomy or denervation surgery involving the neck or shoulder region or deep brain stimulation to treat CD
- •Cervical contracture that limited passive range of motion
- •Physiotherapy initiated <4 weeks before study entry or expected to be initiated during the study
- •Treatment with aminoglycoside antibiotics within 30 days prior to study treatment
- •Current or expected requirement for concomitant medication that could interfere with the evaluation of study treatment
- •Pregnant and/or lactating females
- •Females of childbearing potential with a positive prestudy urine pregnancy test (a positive urine pregnancy test could be confirmed by a serum pregnancy test at the discretion of the investigator) and subjects, or their partners, who did not agree to use adequate contraception (hormonal or barrier method of birth control) prior to injection of study treatment and for the duration of study participation. Nonchildbearing potential is defined as postmenopause for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy
- •Individuals who had family or employee relationship to study site staff or sponsor staff involved in the conduct of the study
- •Any medical condition that could, as judged by the investigator, compromise compliance with the objectives and procedures of this protocol or preclude the administration of BoNT, including swallowing and other respiratory abnormality.
- •Subjects who were unable and/or unwilling to comply fully with the protocol and the study instructions, as judged by the investigator
研究组 & 干预措施
Dysport®
Dysport®, up to 500 units (U)/vial using 2mL dilution
干预措施: Botulinum toxin type A (Biological)
结局指标
主要结局
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.
时间窗: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)
Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
次要结局
- Treatment Response in Treatment Cycle 3 Week 4.(Week 4 Treatment Cycle 3)
- TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.(Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each))
- TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.(Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each))
- TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.(Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each))
- TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.(Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each))