EUCTR2005-000709-70-DE进行中（未招募）1 期
A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Ltd
- 入组人数
- 116
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
- •a) Signed informed consent
- •b) Male or female of 18 years of age or older
- •c) Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pretreatment status.
- •d) TWSTRS meeting the following criteria at baseline
- •i. TWSTRS -Total score = 30
- •ii. TWSTRS -Severity Sub-scale score = 15
- •iii. TWSTRS -Disability Sub-scale score = 3
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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
- •a) Pure anterocollis or pure retrocollis
- •b) In apparent remission from cervical dystonia
- •c) 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 botulinum toxin type A or type B treatments
- •d) Known requirement for fewer than 80 or more than 250 BOTOX® units injected into the neck muscles, or fewer than 4,000 or more than 12,500 units of type B toxin
- •e) Subjects that are being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
- •f) Requirement for botulinum toxin injection to site(s) of the body other than the neck and unable to avoid such treatment(s) for the duration of the study
- •g) Known hypersensitivity to botulinum toxin or related compounds, or any component in the study drug formulation
- •h) Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
- •i) Myasthenia gravis, other disease of the neuromuscular junction or clinically significant, persistent neuromuscular weakness, or disease or symptoms that can interfere with the TWSTRS scoring
- •j) Total body weight less than 100 lbs (45.4 kg)
- •k) Previous phenol injections to the neck muscles
- •l) Previous myotomy or denervation surgery involving the neck or shoulder region
- •m) Cervical contracture that limits passive range of motion
- •n) Treatment with aminoglycoside antibiotics within the last 30 days prior to study treatment.
- •o) 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 six 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 cervical dystonia
- •treatment constant throughout the study, however, changes in pain medication are acceptable if absolutely necessary according to clinical judgment).
- •p) Received any investigational new drug or device within 30 days prior to inclusion in the study q) Previously treated in this study
- •r) 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-menopause for at least 1 year, surgical sterilization at
- •least three months before entering screening, or hysterectomy
- •s) Any medical condition or laboratory finding that compromises
- •compliance with the objectives and procedures of this protocol or precludes the administration of botulinum toxin, as judged by the investigator
- •t) In the opinion of the investigator the subject is unable and/or unwilling to comply fully with the protocol and the study instructions
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