INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)
Status:
Not yet recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
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.