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

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

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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