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Prospective, Open-label, Non-randomized, Single-arm, Dose Titration Study to Investigate the Efficacy and Safety of IncobotulinumtoxinA in Children Deemed to Require a Total Body Dose up to 22U/kg (Maximum Dose 550U) During the Study Period for the Treatment of Upper and Lower Limb Spasticity Due to Cerebral Palsy (INCIPIT)
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.
Details
| Lead sponsor | Universita di Verona |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 30 |
| Start date | 2022-06 |
| Completion | 2025-05 |
Conditions
- Spastic Cerebral Palsy
Interventions
- IncobotulinumtoxinA 100 UNT [Xeomin]
Primary outcomes
- Ashworth Scale — During the screening assessment
The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). - Ashworth Scale — Immediately before each IncobotulinumtoxinA treatment session
The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). - Ashworth Scale — During the follow-up clinical assessment at 4 weeks from each injection
The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). - Ashworth Scale — During the follow-up clinical assessment at 12 weeks from each injection
The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).