EUCTR2010-019907-43-PT进行中（未招募）不适用
A phase III, randomised, double blind and open label phase, active and placebo controlled study comparing the short term efficacy of two formulations of clostridium botulinum type A toxin (Dysport and Dysport RU) to placebo, and assessing the short and long term efficacy and safety of Dysport RU following repeated treatments of subjects with cervical dystonia (CD).
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All subjects must fulfil the following inclusion criteria to be eligible for the study:
- •(1) Provision of written informed consent prior to any study related procedures being carried out. In this study consent may be provided by the legal guardian or caregiver.
- •(2) Male or female of legal age of consent for each participating country (i.e. =18 years).
- •(3) Cervical Dystonia with at least 18 months duration since onset.
- •(4) Previously untreated with BTX-A or -B or if previously treated with BTX-A or -B, a minimum of 14 weeks since the last injection must have elapsed.
- •(5) Toronto Western Spasmodic Torticollis Rating Scale scores meeting the following criteria at baseline:
- •- TWSTRS - Total score =30.
- •- TWSTRS - Severity Sub-scale score =15.
- •- TWSTRS - Disability Sub-scale score =3.
- •- TWSTRS - Pain Sub-scale score =2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will not be included in the study if any of the following are present/apply:
- •(1) Known hypersensitivity to BTX or related compounds, or any component in the study drug formulations (including cow milk protein).
- •(2) Pure anterocollis or pure retrocollis.
- •(3) In apparent remission from CD.
- •(4) Previous poor response as determined by standard practice at each site, (e.g. <20% improvement in TWSTRS total score from baseline to Week 4) to the last two BTX-A or -B treatments.
- •(5) A known requirement for fewer than 80 or more than 300 BOTOX® units injected into the neck muscles, fewer than 4,000 U or more than 12,500 U of BTX-B, or <250 U or >1000 U of Dysport.
- •(6) Subjects that are being treated with BTX-B due to lack of efficacy to BTX-A or have known neutralising antibodies to BTX-A.
- •(7) A requirement for BTX injection(s) into site(s) of the body other than the neck and unable to avoid such treatment(s) for the duration of the study.
- •(8) A known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.
- •(9) Have sub-clinical or clinical evidence of marked defective neuromuscular transmission (e.g. myasthenia gravis) or persistent clinically significant neuromuscular weakness or a condition that would interfere with TWSTRS scoring.
- •(10) A total body weight less than 100 lbs (45.4 kg).
- •(11) Previous phenol or alcohol injections into the neck muscles.
- •(12) Previous myotomy or denervation surgery involving the neck or shoulder region.
- •(13) Cervical contracture that limits passive range of motion.
- •(14) Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) within the last 30 days prior to study treatment.
- •(15) A current or expected requirement for concomitant medication that may interfere with the evaluation of study treatment (e.g. narcotics).
- •NOTE: muscle relaxants and benzodiazepines are permitted if the dosage has been stable for the 6 weeks prior to study treatment and is expected to remain at this stable dose until the Week 4 assessment. Every effort should be made to keep concomitant CD treatment constant throughout the study, however, changes in pain medication are acceptable if absolutely necessary according to clinical judgment.
- •(16) Any medical condition or laboratory finding that might compromise compliance with the objectives and procedures of this protocol or preclude the administration of BTX-A, as judged by the Investigator (including infection at the site for injection).
- •(17) In the opinion of the Investigator the subject is unable and/or unwilling to comply fully with the protocol and/or the study instructions.
- •(18) Was treated with any other IMP or device within the last 30 days before study entry.
- •(19) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- •(20) Pregnancy or lactation: women of child-bearing potential must have a negative pre-study urine pregnancy test and subjects, or their partner, must agree to use adequate contraception (hormonal or barrier method of birth
- •control) prior to injection of study drug and for the duration of study participation. Non-childbearing potential is defined as post-menopausal for
- •at least 1 year, surgical sterilisation at least three months before entering screening, or hysterectomy.
- •(21) Previously treated in this study.
- •(22) Has a history of, or known current probl
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