Pediatric lower limb (LL) spasticity (SP) caused by cerebral palsy (CP) MedDRA version: 20.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852 MedDRA version: 21.1 Level: LLT Classification code 10024132 Term: Leg spasticity System Organ Class: 100000004852 MedDRA version: 20.1 Level: LLT Classification code 10021740 Term: Infantile cerebral palsy System Organ Class: 100000004850
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female subjects = 2 to = 17 years of age; • Bilateral, symmetrical pes equinus due to LL SP caused by CP in subjects with any Gross Motor Function Classification System (GMFCS) level; and • Identical MAS plantar flexor score of = 2 for pes equinus clinical patterns in both legs at neutral ankle position and knee at maximum extension. Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Pre-dominant forms of muscle hypertonia/hyperactivity other than LL SP (e.g., rigidity, dystonia, dyskinesia); • Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in any body region within the last four months before injection at baseline visit; and • Fixed contracture in at least one of both pes equinus. • Significant involuntary movements or limitations that hinder MAS assessment or positioning. • Clinically significant SP in LL clinical patterns other than pes equinus; or gait patterns drop foot, crouch gait, and equinus with jump knee. • Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30°.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate efficacy by showing superiority of NT 201 compared intra-individually to placebo in children and adolescents with LL SP caused by CP at week 4 to week 6 after a single injection.;Secondary Objective: To demonstrate the relevance of the effect of NT 201 compared to placebo in children and adolescents with LL SP caused by CP in terms of response rates in derived MAS score of plantar flexors at week 4 or week 6 after a single injection. To demonstrate the relevance of the effect of NT 201 compared to placebo in children and adolescents with LL SP caused by CP assessed on a Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) at week 4 to week 6 after a single injection. To demonstrate the relevance of the effect of NT 201 compared to placebo in children and adolescents with LL SP caused by CP assessed on a Goal Attainment Scale (GAS) at week 4 to week 6 after a single injection.;Primary end point(s): Change in derived modified Ashworth Scale (MAS) score of plantar flexors from baseline at control visits at week 4 and week 6.;Timepoint(s) of evaluation of this end point: From baseline to week 4 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary End Point 1: Response in derived MAS score of plantar flexors at control visits at week 4 or week 6 with response defined as improvement of at least 1 point on the derived MAS score as compared to study baseline. Secondary End Point 2: GICS-PF score at control visits at week 4 and week 6 by investigator. Secondary End Point 3: GAS T-score at control visits at week 4 and week 6.;Timepoint(s) of evaluation of this end point: Secondary End Point 1: From baseline to week 4 or week 6 Secondary End Point 2: Week 4 and week 6 Secondary End Point 3: Week 4 and week 6 | — |
Countries
Latvia, Poland, Russian Federation, Ukraine
Contacts
Public ContactPublic Disclosure Manager
Merz Pharmaceuticals GmbH
Outcome results
None listed