A clinical study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity in children and adolescents with cerebral palsy.

Who can take part

• 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
• Identical MAS plantar flexor score of ≥ 2 for pes equinus clinical patterns in both legs at neutral ankle position and knee at maximum extension
• Main eligibility criteria for Open-Label Extension Period (OLEX): MAS plantar flexor score of ≥ 1 in both pes equinus clinical patterns
• Main eligibility criteria for Open-Label Extension Period (OLEX): Agreement of investigator, parent(s), and subject (if applicable) to continue treatment

Who cannot take part

• Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in any body region within the last four months before injection at baseline visit
• Pre-dominant forms of muscle hypertonia/hyperactivity other than LL SP (e.g., rigidity, dystonia, dyskinesia)
• 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°