The WE-Study - Walking Easier with cerebral palsy
- Conditions
- cerebral palsyMedDRA version: 20.1Level: LLTClassification code 10021740Term: Infantile cerebral palsySystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-002539-32-PL
- Lead Sponsor
- St. Olavs University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether injections of BoNT-A in the calf muscles (mm. gastrocnemius and soleus) make walking easier in children with cerebral palsy within a time span of 6 months. ;Secondary Objective: To evaluate whether an improvement in energy cost during walking is associated with less pain, increased daily activity and perceived improved performance and satisfaction.;Primary end point(s): energy cost during walking, measured during a 5-minutes submaximal Walk Test (5MWT) at a self-chosen velocity with simultaneous gas-exchange measurements;Timepoint(s) of evaluation of this end point: at baseline, 4, 12, 24 weeks
- Secondary Outcome Measures
Name Time Method