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: 19.1Level: LLTClassification code 10058977Term: Spastic paresisSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-005496-14-Outside-EU/EEA
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-22
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: A
• 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