Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children (PUL)

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Ipsen

Status and phase

Completed
Phase 3

Conditions

Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02106351
2010-021817-22 (EudraCT Number)
Y-52-52120-153

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).

Enrollment

212 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Upper limb spasticity due to cerebral palsy
  • Body weight 10 kg or over
  • MAS score of 2 or more in affected elbow or wrist flexors

Exclusion criteria

  • Fixed myocontracture
  • Previous phenol or alcohol injection within 1 year
  • Severe athetoid or dystonic movements
  • Previous or planned surgery for spasticity in elbow or wrist flexors
  • Neuromuscular disorders
  • Previous Rhizotomy within 6 months
  • Intrathecal baclofen within 30 days

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

212 participants in 3 patient groups

Group A
Experimental group
Description:
Group A - Treatments 1, 2, 3 and 4: Dysport 16 Units (U)/kg in one upper extremity (the study limb).
Treatment:
Biological: Botulinum toxin type A
Group B
Experimental group
Description:
Group B - Treatments 1, 2, 3 and 4: Dysport 8 U/kg in one upper extremity (the study limb).
Treatment:
Biological: Botulinum toxin type A
Group C
Experimental group
Description:
Group C - Treatment 1: Dysport 2 U/kg in one upper extremity (the study limb). Group C - Treatments 2, 3 and 4: Dysport 8 or 16 U/kg in one upper extremity (the study limb).
Treatment:
Biological: Botulinum toxin type A

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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