Prospective 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

Phase 1

• Conditions: Multifocal spasticity of the upper and lower limb due to cerebral palsy; MedDRA version: 20.0Level: PTClassification code 10028335Term: Muscle spasticitySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: LLTClassification code 10033560Term: Palsy cerebralSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003559-12-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Children (female or male) aged 2 to 17 years
• 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 associate with the selected target clinical pattern [12]
• Patients 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 last injection at least 5 months
• Informed consent signed by parents
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Participation in other trials
• BoNT-A treatment contraindicated
• Presence of fixed contractures, or bony deformities of the affected limbs
• Previous treatment of spastic muscles with nerve phenolization
• Other neurological or orthopedic conditions involving the affected limbs
• institutionalized patients
• girls with childbearing potential (defined as females post menarche)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified