INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)

Sponsor
Universita di Verona
Study ID
NCT05340439
Phase
PHASE2
Status
Unknown

Conditions

  • Spastic Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • IncobotulinumtoxinA 100 UNT [Xeomin] — DRUG
    In cycle 1, a total body dose of 16U/kg (maximum 400U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs. In cycle 2, a total body dose of 19U/kg (maximum 475U) of IncobotulinumtoxinA will be injected. 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. In cycle 3, a total body dose of 22U/kg (maximum 550U) of IncobotulinumtoxinA will be injected. 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 600U) may be administered in the cycle 3 (if the patient has been treated with 16U/kg in cycle 2, a dose of 19U/kg may be injected in cycle 3).

Study Details

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.

Key Dates

Start date
Jun 30, 2022
Status verified
Apr 2022
Primary completion
Jan 31, 2024
Completion
May 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Incobotulinumtoxin A treatment
    The study will consist of three injection cycles. In each, an injection visit is followed by an observation period of 12 to 20 weeks.

Primary Outcome Measure

Ashworth Scale [ Time Frame: During the screening assessment ]

Central Contacts

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