EUCTR2014-002539-32-NO
Active, not recruiting
Phase 1
The WE Study - Walking Easier with cerebral palsy
St. Olavs University Hospital0 sites96 target enrollmentDecember 3, 2014
Conditionscerebral palsyMedDRA version: 20.1Level: LLTClassification code 10021740Term: Infantile cerebral palsySystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsBotox
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- cerebral palsy
- Sponsor
- St. Olavs University Hospital
- Enrollment
- 96
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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