Multifocal spasticity of the upper and lower limb due to cerebral palsy MedDRA version: 20.0 Level: PT Classification code 10028335 Term: Muscle spasticity System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10033560 Term: Palsy cerebral System Organ Class: 100000004850
Conditions
Interventions
Trade Name: XEOMIN - 100 UNITA' DL50 POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO DI VETRO
Product Name: IncobotulinumtoxinA
Product Code: [IncobotulinumtoxinA]
Pharmaceutical Form: Powder for solut
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children (female or male) aged 2 to 17 years • Patients with upper and lower limb spasticity due to cerebral palsy • Gross Motor Function Classification System (GMFCS) from Level II to Level V • Selected target clinical pattern diagnosed by a qualified health care professional (i.e. physiatrist) • Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associate with the selected target clinical pattern [12] • Patients deemed by the investigator to require a total body dose up to 22U/kg (maximum 550U) during the study period • In the case of children pretreated with BoNT-A, time from last injection at least 5 months • Informed consent signed by parents Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria
Exclusion criteria: • Participation in other trials • BoNT-A treatment contraindicated • Presence of fixed contractures, or bony deformities of the affected limbs • Previous treatment of spastic muscles with nerve phenolization • Other neurological or orthopedic conditions involving the affected limbs • institutionalized patients • girls with childbearing potential (defined as females post menarche)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of IncobotulinumtoxinA in the treatment of both BoNT-A naïve and pretreated children for upper and lower limb spasticity using a dose titration approach over three injection cycles, with a flexible observation period after injection of 12 to 20 weeks and a total duration of exposure up to 60 weeks;Secondary Objective: To investigate the safety of IncobotulinumtoxinA in the treatment of both BoNT-A naïve and pretreated children for upper and lower limb spasticity using a dose titration approach over three injection cycles, with a flexible observation period after injection of 12 to 20 weeks and a total duration of exposure up to 60 weeks.;Primary end point(s): Changes in Ashworth scale values between the injection cycle baseline visits and the control ones of respective injection cycle (single interventional effect).;Timepoint(s) of evaluation of this end point: V2 vs V3, V5 vs V6, V8 vs V9 V2 vs V10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoint: Ashworth scale; Efficacy endpoints - REsistance to PAssive movement Scale (REPAS) - The GMFCS - The visual analog scale (VAS); Efficacy endpoints - The Goal Attainment scale (GAS) - The Global Assessment of Efficacy; Safety endpoints: Valori di pressione, frequenza cardiaca e frequenza respiratoria; Peso; eventi avversi;Timepoint(s) of evaluation of this end point: V2 vs V6 V2 vs V9 V2 vs V5 V2 vs V8; V2 vs V3, V5 vs V6, V8 vs V9 V2 vs V6 V2 vs V9 V2 vs V5 V2 vs V8 V2 vs V10; V5, V8, V10; V1, V2, V3, V4, V5, V6, V7, V8, V9, V10 V2 vs V4 V2 vs V7 V2 vs V10; V1, V2, V5, V8; from V2 and during the study | — |
Countries
Italy
Contacts
Public ContactUOC Neuroriabilitazione
Azienda Ospedaliera Universitaria Integrata verona
Outcome results
None listed