Status:
UNKNOWN
INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)
Lead Sponsor:
Universita di Verona
Conditions:
Spastic Cerebral Palsy
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
Prospective, open-label, non-randomized, single-arm, dose titration, phase II study. The study will consist of three injection cycles. In each, an injection visit is followed by an observation period...
Detailed Description
The population involved will be children (either BoNT-A treatment-naïve or pre-treated) with multifocal spasticity of the upper and lower limb due to cerebral palsy, scheduled to receive at least one ...
Eligibility Criteria
Inclusion
- Patients with upper and lower limb spasticity due to cerebral palsy
- Gross Motor Function Classification System (GMFCS) from Level II to Level V
- Selected target clinical pattern diagnosed by a qualified health care professional (i.e. physiatrist)
- Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associated with the selected target clinical pattern
- Patient deemed by the investigator to require a total body dose up to 22U/kg (maximum 550U) during the study period
- In the case of children pretreated with BoNT-A, time from the last injection at least 5 months
- Informed consent signed by parents or legal guardian.
Exclusion
- Participation in other trials
- BoNT-A treatment contraindicated
- Therapy with anticoagulants or other substances that could have an anticoagulant effect
- Girls of childbearing potential (defined as females post menarche)
- Presence of fixed contractures, or bony deformities of the affected limbs
- Previous treatment of spastic muscles with nerve penalization
- Other neurological or orthopaedic conditions involving the affected limbs.
- Specific vulnerable populations:
- institutionalized patients will not be included
- girls of childbearing potential (defined as females with a history of menarche) will not be included.
- Withdrawal criteria for single patients:
- Serious adverse event (SAE)
- Development of dysphagia and/or aspiration pneumonia.
- Withdrawal of consent
- Inability to follow the study according to its design and time points
- Co-administration of aminoglycoside antibiotics, spectinomycin, 4-aminoquinoline, anticholinergic drugs, AbobotulinumtoxinA, OnabotulinumtoxinA or other agents interfering with neuromuscular transmission (e.g., tubocurarine-type muscle relaxants).
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05340439
Start Date
June 1 2022
End Date
May 1 2025
Last Update
April 22 2022
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