Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy

Sponsor
Merz Pharmaceuticals GmbH
Study ID
NCT02188277
Phase
PHASE2
Status
Completed

Conditions

  • Cerebral Palsy
  • Equine and Equinovarus Foot Deformation
  • Spastic Paraplegia and Hemiparesis

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Xeomin — DRUG
    Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
  • Botox® — DRUG
    Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.

Study Details

1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy 2. To assess the safety of Xeomin® use as compared to Botox® in this patient population

Key Dates

Start date
Jul 31, 2014
Status verified
Jan 2017
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Xeomin®
    4-8 Units per kg body weight. Single injection cycle.
  • Active Comparator: Botox®
    4-6(8) Units per kg body weight. Single injection cycle.

Primary Outcome Measure

Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS) [ Time Frame: From baseline to day 30 ]

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