INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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 of 12 to 20 weeks.

During cycle 1, a total body dose of 16U/kg (maximum 400U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs.

During cycle 2, a total body dose of 19U/kg (maximum 475U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs. If a dose of 19U/kg is not justified (i.e., for clinical or safety reasons) but BoNT-A treatment is still needed (according to the clinical condition of patients) the same dose injected in cycle 1 (16U/Kg; maximum 400U) may be administered in the cycle 2.

During cycle 3, a total body dose of 22U/kg (maximum 550U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs. If a dose of 22U/kg is not justified (i.e., for clinical or safety reasons) but BoNT-A treatment is still needed (according to the clinical condition of patients) the same dose injected in cycle 2 (19U/Kg; maximum 475U) may be administered in the cycle 3.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universita di Verona
• Treatments: incobotulinumtoxinA

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).