Measuring effects on pain and quality of life after botulinium injections (DYSPORT® ) in children with cerebral palsy

Phase 1

• Conditions: Muscle pain in the extremities due to spasticity in children with cerebral palsy; MedDRA version: 20.0Level: LLTClassification code 10028322Term: Muscle painSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10041418Term: Spasticity muscleSystem Organ Class: 100000004852; MedDRA version: 20.1Level: LLTClassification code 10021745Term: Infantile cerebral palsy, unspecifiedSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004497-33-DK
• Lead Sponsor: Copenhagen University Hospital at Hvidovre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-22
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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): <br>;Timepoint(s) of evaluation of this end point: 1-2 weeks pre injection and 4, 12, 28 weeks post injection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints<br>Different pain scores: <br>Paediatric Pain Profile (PPP) <br>Wong-Baker pain scale (3-8) <br>Visual analogue Scale (VAS) (8y+): <br>Quality of life questionaire: CPchild, CPQQL<br><br>Tertiary endpoints : <br>Spasticity (Tardieu scale and modified Ashworth scale) and Passive range of motion of the muscles being treated<br>Goal attainment scale<br>Modified House Classification (MHC)<br>Bilateral Hand function<br>Thumb in palm<br>Measurement of spasticitet - dynamic component using the NeuroFlexor<br>;Timepoint(s) of evaluation of this end point: 1-2 weeks pre injection and 4, 12, 28 weeks post injection