EUCTR2017-004497-33-DK
Active, not recruiting
Phase 1
Measuring effects on pain and quality of life after Dysport® injection in children with cerebral palsy
Copenhagen University Hospital at Hvidovre0 sites36 target enrollmentDecember 22, 2017
ConditionsMuscle pain in the extremities due to spasticity in children with cerebral palsyMedDRA version: 20.0Level: LLTClassification code 10028322Term: Muscle painSystem Organ Class: 100000004859MedDRA version: 20.0Level: LLTClassification code 10041418Term: Spasticity muscleSystem Organ Class: 100000004852MedDRA version: 20.1Level: LLTClassification code 10021745Term: Infantile cerebral palsy, unspecifiedSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Muscle pain in the extremities due to spasticity in children with cerebral palsy
- Sponsor
- Copenhagen University Hospital at Hvidovre
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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