EUCTR2014-002539-32-PL进行中（未招募）1 期
The WE-Study - Walking Easier with cerebral palsy
St. Olavs University Hospital0 个研究点目标入组 96 人开始时间: 2018年10月17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
- 96
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
- •Eligible to participate in the study are children and adolescents with spastic cerebral palsy referred to the out-patient clinics at the participating sites and regional partners, for injection of BoNT-A in the calf muscles.
- •All of the following conditions must apply to the prospective patient at screening prior to receiving study agent (e.g.):
- •Diagnosed with unilateral or bilateral CP in their medical record
- •GMFCS level I and II
- •Age range 4-17.
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •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
- •Patients will be excluded from the study if they meet any of the following criteria:
- •BoNT-A injections in the lower limbs in the last 6 months before intervention
- •History of adverse reactions to BoNT-A
- •Known hypersensitivity to BoNT-A or to any of the excipients
- •Orthopedic surgery in the lower limbs in the last 2 years
- •Major cognitive impairments (must be able to take verbal instructions and conduct the test procedure)
- •Presence of infection at the proposed injection site(s)
- •Subclinical or clinical evidence of defective neuromuscular transmission e.g. myasthenia gravis or Lambert-Eaton Syndrome in patients with peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy) or other underlying neurological disorders that may be affected by BoNT-A injections
- •Pregnant or breast-feeding
- •Childbearing potential not using contraception
- •Any reason why, in the opinion of the investigator, the patient should not participate
- •Children in need for deep sedation under treatment. Children receiving concurrent injections in the upper limbs where deep sedation is standard procedure, are not excluded
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