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: 2014年12月3日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•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
•Must be at least 4 years of age.
•Spasticity in the calf muscles, clinically judged as grade 2 or 3 (the presence of a spastic catch) according to the Tardieu Scale.
•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: 96
•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

•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

发起方

St. Olavs University Hospital