EUCTR2010-021817-22-CZ进行中（未招募）1 期
A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, CONTROLLED, MULTIPLE TREATMENT STUDY ASSESSING EFFICACY AND SAFETY OF DYSPORT USED IN THE TREATMENT OF UPPER LIMB SPASTICITY IN CHILDRE
IPSEN INNOVATIO0 个研究点目标入组 210 人开始时间: 2013年12月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •((1) Signed informed consent obtained from the child’s parent(s)/guardian(s) and, if applicable, a signed assent from the child.
- •(2) Be from 2 to 17 years of age, inclusive.
- •(3) Body weight of 10 kg or more at the baseline visit.
- •(4) Have a diagnosis of CP, as defined by Rosenbaum.
- •(5) Have increased muscle tone/spasticity in at least one upper limb.
- •(6) Have a MAS score =2 in the upper limb primary targeted muscle group (elbow flexors or wrist flexors) of the study limb (the limb to be injected in the first treatment) at the baseline visit.
- •(7) Be classified as Gross Motor Function Classification System Level 1 to 4.
- •(8) If undergoing therapy, such as physiotherapy, occupational therapy, or use of splints and/or orthoses, therapy must have been initiated at least 30 days prior to the baseline visit and agreed to continue the therapy throughout the study and at the minimum, up to Week 16 following the first treatment administration.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 210
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) Fixed myocontracture in the primary targeted muscle group (elbow flexors or wrist flexors) of the study limb defined as having an available range of motion angle of <40°, regardless of the starting and finishing angles, measured at the Tardieu Scale (TS) slow (XV1) speed at the baseline visit. (Available range for wrist flexors should be measured without holding the fingers and allowing free finger flexion).
- •(2) Subjects likely to be treated with BTX in the lower limb(s) and/or the nonstudy upper limb before Treatment 2 of the study.
- •(3) Inadequate washout from previous BTX injection of any serotype for any condition:
- •Within 6 months prior to the baseline visit in the study limb,
- •Within 3 months prior to the baseline visit in any other part of the body.
- •(4) Subjects who require BTX treatment in a single muscle group in the study limb in Treatment 1.
- •(5) Severe athetoid or dystonic movements in the study limb.
- •(6) Previous or planned surgery for spasticity in the primary targeted muscle group(s) of the study limb.
- •(7) Previous injection of alcohol and/or phenol within 1 year prior to the baseline visit affecting the study limb wrist flexors and/or elbow flexors selected for injection in Treatment 1.
- •(8) Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study treatment.
- •(9) Are pregnant and/or lactating.
- •(10) Female subjects not willing to use contraceptive measures throughout the course of the study if postpubertal and sexually active.
- •(11) Inability or unwillingness to comply with the protocol.
- •(12) Subjects with any clinical (or sub-clinical) evidence of marked defective neuromuscular transmission (e.g. Lambert-Eaton syndrome or myasthenia gravis) or persistent clinically significant neuromuscular disorders.
- •(13) Known sensitivity to BTX or to any of the components in the formulation or allergy to cow’s milk protein.
- •(14) An infection at the injection site(s).
- •(15) Previous rhizotomy less than 6 months prior to the baseline visit or rhizotomy planned/anticipated during the course of the study.
- •(16) Subjects treated or likely to be treated with intrathecal baclofen within 30 days prior to the baseline visit or during the course of the study.
- •(17) Treatment with a new investigational drug within 30 days prior to the baseline visit or scheduled to receive such a drug during the course of the study.
- •(18) Subjects with a history of aspiration or conditions which put them at risk of aspiration, such as severe dysphagia.
- •(19) Concurrent or history of frequent lower respiratory tract infections, aspiration pneumonia, or, as judged by the Investigator, has compromised respiratory function.
- •(20) Any known medical condition, laboratory or diagnostic procedure finding, which might compromise compliance with the objectives and procedures of this protocol or preclude administration of botulinum toxin type A (BTX-A), as judged by the Investigator.
- •(21) Any uncontrolled clinically significant medical condition other than CP.
研究者
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