Open-label, Non-controlled, Multicenter Long-term Study to Investigate the Safety and Efficacy of Xeomin® (Incobotulinumtoxin A, NT 201) for the Treatment of Spasticity of the Lower Limb(s) or of Combined Spasticity of Upper and Lower Limb in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy
Open-label, Non-controlled, Multicenter Long-term Study to Investigate the Safety and Efficacy of Xeomin® (Incobotulinumtoxin A, NT 201) for the Treatment of Spasticity of the Lower Limb(s) or of Combined Spasticity of Upper and Lower Limb in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Inclusion Criteria:
Main clinical inclusion criteria for completers of study MRZ60201_3070_1:
Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus and need for additional 8 U/kg BW NT 201 (maximum of 200 U) for treatment of clinical pattern flexed knee or adducted thigh (ipsilateral) or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus on each side.
No treatment of other clinical patterns is allowed.
Main clinical inclusion criteria for subjects who did not participate in MRZ60201_3070_1:
Female or male subject of 2 to 17 years age (inclusive).
Uni- or bilateral CP with clinical need for BoNT injection to treat limb spasticity.
AS score ≥ 2 in plantar flexors (at least unilaterally).
Clinical need according to the clinical judgment of the investigator in one out of four treatment combinations:
Exclusion Criteria:
Exclusion Criteria for subjects who completed MRZ60201_3070_1:
Exclusion Criteria for subjects who did not participate in MRZ60201_3070_1:
Fixed contracture defined as severe restriction of the range of joint movement on passive stretch in the target clinical pattern(s) or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s).
Surgery in the pes equinus on side(s) intended to treat with BoNT injections within 12 months prior to Screening Visit (V1), within the screening period or planned for the time of participation in this study.
Hip flexion requiring BoNT injection.
Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30.
Vaccination within 2 weeks prior to Screening Visit (V1) and/or within the screening period.
Non-resolved fractures of the treated limb.
Ventilator dependency.
Severe neurological diagnosis and comorbidity outside the spectrum of cerebral palsy.
Pure dyskinetic CP or mixed CP with predominantly dyskinetic movements.
Treatment with BoNT (other than study drug in this study) for any body region within 14 weeks prior to Screening Visit (V1), within the screening period and/or intended to be administered during the study period.
Treatment with phenol or alcohol of any muscle within 6 months prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period.
Treatment with