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

Phase 1

• Conditions: Pediatric lower limb (LL) spasticity (SP) caused by cerebral palsy (CP); MedDRA version: 20.0Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852; MedDRA version: 21.1Level: LLTClassification code 10024132Term: Leg spasticitySystem Organ Class: 100000004852; MedDRA version: 20.1Level: LLTClassification code 10021740Term: Infantile cerebral palsySystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-001634-18-PL
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

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

• 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°.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified