Muscle pain in the extremities due to spasticity in children with cerebral palsy MedDRA version: 20.0 Level: LLT Classification code 10028322 Term: Muscle pain System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10041418 Term: Spasticity muscle System Organ Class: 100000004852 MedDRA version: 20.1 Level: LLT Classification code 10021745 Term: Infantile cerebral palsy, unspecified System Organ Class: 100000004850
Conditions
Interventions
Trade Name: DYSPORT® (abotulinumtoxinA)
Product Name: DYSPORT® (abotulinumtoxinA)
Pharmaceutical Form: Injection
INN or Proposed INN: Botulinum toxin A
Other descriptive name: BOTULINUM TOXIN A - HAEM
Sponsors
Copenhagen University Hospital at Hvidovre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosed with spastic cerebral palsy - GFMCS 1-5. - Age 2-18 - Having a pain response by the revised and individualized Face Legs Activity Cry and Consolability (rFLACC) for muscles with spasticity (MAS score = 1 and a spasticity grade of 1-4 on the Tardieu scale) during the passive range of motion by the treating physician. - Requiring BonTA injection for their spasticity - having had a washout period of at least 6 month from last injection of botulinum toxin - Dynamic Myocontracture /spasticity in the painful limb (MAS score = 1 and a spasticity grade of 1-4 on the Tardieu scale) Are the trial subjects under 18? yes Number of subjects for this age range: 36 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
Exclusion criteria: - Fixed myocontracture (Reduced and static passive range of motion) - Severe athetoid/dystonic movements in the targeted leg(s) Relative exclusion criteria Prior and recent surgery that might influence the pain evaluation is a contraindication and will be evaluated on an individual basis for the specific test subject by the principle investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the effect of botulinum toxin injections in regards to pain and quality of life in children with cerebral Palsy;Secondary Objective: Not applicable;Primary end point(s): The revised Face, Legs Activity, Cry, Consolability Scale (r-FLACC): ;Timepoint(s) of evaluation of this end point: 1-2 weeks pre injection and 4, 12, 28 weeks post injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints Different pain scores: Paediatric Pain Profile (PPP) Wong-Baker pain scale (3-8) Visual analogue Scale (VAS) (8y+): Quality of life questionaire: CPchild, CPQQL Tertiary endpoints : Spasticity (Tardieu scale and modified Ashworth scale) and Passive range of motion of the muscles being treated Goal attainment scale Modified House Classification (MHC) Bilateral Hand function Thumb in palm Measurement of spasticitet - dynamic component using the NeuroFlexor ;Timepoint(s) of evaluation of this end point: 1-2 weeks pre injection and 4, 12, 28 weeks post injection | — |
Countries
Denmark
Contacts
Public ContactChristian Wong
Copenhagen University Hospital at Hvidovre
Outcome results
None listed