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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. PROTOCOL CODE: INCIPIT

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518447-38-00
Acronym
INCIPIT
Enrollment
30
Registered
2024-10-29
Start date
2023-02-10
Completion date
Unknown
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multifocal spasticity of the upper and lower limb due to cerebral palsy

Brief summary

Changes in Ashworth scale values between the injection cycle baseline visits and the control ones of respective injection cycle (single interventional effect)

Detailed description

Efficacy endpoint: Scala di Ashworth, REsistance to PAssive movement Scale (REPAS), The GMFCS, The visual analog scale (VAS), The Goal Attainment scale (GAS), The Global Assessment of Efficacy, Safety endpoints: Values of blood pressure, heart rate, and respiratory rate, Values of Body Weight, adverse events, The Global Assessment of Tolerability

Interventions

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Changes in Ashworth scale values between the injection cycle baseline visits and the control ones of respective injection cycle (single interventional effect)

Secondary

MeasureTime frame
Efficacy endpoint: Scala di Ashworth, REsistance to PAssive movement Scale (REPAS), The GMFCS, The visual analog scale (VAS), The Goal Attainment scale (GAS), The Global Assessment of Efficacy, Safety endpoints: Values of blood pressure, heart rate, and respiratory rate, Values of Body Weight, adverse events, The Global Assessment of Tolerability

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026