Dose-response study of efficacy and safety of Botulinum toxin type A to treat spasticity of the arm(s) or of arm(s) and leg(s) in cerebral palsy

Phase 1

Conditions: pper limb spasticity or combined upper and lower limb spasticity in children and adolescents(age 2 - 17 years) with cerebral palsy
MedDRA version: 20.0Level: LLTClassification code 10058977Term: Spastic paresisSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-005496-14-PL

Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 344

Inclusion Criteria

- Female or male subject of 2 to 17 years of age (inclusive).
- Uni- or bilateral cerebral palsy CP with clinical need for injections with NT 201 for the treatment of upper limb spasticity at least unilaterally.
- Ashworth Scale (AS) score in the main clinical target patterns in this study: a.Flexed elbow: AS=2 in elbow flexors (at least unilaterally). And/or b.Flexed Wrist: AS=2 in wrist flexors (at least unilaterally).
- Clinical need according to the judgment of the investigator in one out of five treatment combinations.
- AS score must be =2 for each target pattern chosen for injection at the Baseline Injection Visit V2.

Are the trial subjects under 18? yes
Number of subjects for this age range: 344
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

Pre-treated (non-naïve) subjects must not have received BoNT treatment within the last 14 weeks prior to the Screening Visit (V1) in any indication.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.;Secondary Objective: Not applicable;Primary end point(s): Primary Outcome Measures: <br>- Change from baseline in Ashworth Scale (AS) in the primary clinical target pattern, i.e. elbow flexors or wrist flexors at Day 29 (Week 4). <br>Primary clinical target pattern is defined by the investigator. <br>Co-primary outcome measure:<br>- Investigator's Global Impression of Change Scale (GICS) at Day 29 (Week 4). <br><br>;Timepoint(s) of evaluation of this end point: Day 29 (Week 4) of 1st injection cycle of main period.<br>

Secondary Outcome Measures