CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Cerebral palsy | Muscle spasticity

Inclusion criteria

• {"criterion_text":"- Children (female or male) aged 2 to 17 years\n- Patients with upper and lower limb spasticity due to cerebral palsy\n- Gross Motor Function Classification System (GMFCS) from Level II to Level V\n- Selected target clinical pattern diagnosed by a qualified health care professional\n- Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associate with the selected target clinical pattern\n- Patient deemed by the investigator to require a total body dose up to 22U/kg (maximum 550U) during the study period\n- In the case of children pretreated with BoNT-A, time from last injection at least 5 months\n- Informed consent signed by parents or legal guardian"}

Exclusion criteria

• {"criterion_text":"- Participation in other trials\n- BoNT-A treatment contraindicated\n- Therapy with anticoagulants or other substances that could have an anticoagulant effect\n- Girls of childbearing potential (defined as females post menarche)\n- Presence of fixed contractures, or bony deformities of the affected limbs\n- Previous treatment of spastic muscles with nerve phenolization\n- Other neurological or orthopedic conditions involving the affected limbs\n- institutionalized patients"}

Primary endpoints

• {"endpoint_text":"- Changes in Ashworth scale values between the injection cycle baseline visits and the control ones of respective injection cycle (single interventional effect)","definition_or_measurement_approach":"Change in Ashworth scale values measured between injection-cycle baseline visits and corresponding control visits (measured using the Ashworth scale)."}

Secondary endpoints

• {"endpoint_text":"- Efficacy endpoint: Scala di Ashworth","definition_or_measurement_approach":"Measured using the Ashworth scale (Scala di Ashworth)."}
• {"endpoint_text":"- REsistance to PAssive movement Scale (REPAS)","definition_or_measurement_approach":"Measured using the REPAS scale (resistance to passive movement)."}
• {"endpoint_text":"- The GMFCS","definition_or_measurement_approach":"Gross Motor Function Classification System scoring."}
• {"endpoint_text":"- The visual analog scale (VAS)","definition_or_measurement_approach":"Measured using a visual analog scale for pain or relevant symptom."}
• {"endpoint_text":"- The Goal Attainment scale (GAS)","definition_or_measurement_approach":"Measured using the Goal Attainment Scaling methodology."}
• {"endpoint_text":"- The Global Assessment of Efficacy","definition_or_measurement_approach":"Investigator/global assessment of overall efficacy (methodology as per protocol)."}
• {"endpoint_text":"- Safety endpoints: Values of blood pressure, heart rate, and respiratory rate","definition_or_measurement_approach":"Vital signs assessment: blood pressure, heart rate, respiratory rate recorded per visits."}
• {"endpoint_text":"- Values of Body Weight","definition_or_measurement_approach":"Body weight measured at scheduled visits."}
• {"endpoint_text":"- adverse events","definition_or_measurement_approach":"Adverse events collected and reported as per safety reporting procedures."}
• {"endpoint_text":"- The Global Assessment of Tolerability","definition_or_measurement_approach":"Investigator/global assessment of tolerability (methodology as per protocol)."}

Italy

Earliest CTIS Part Ii Submission Date

25-09-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

34

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Azienda Ospedaliera Universitaria Integrata Verona

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Merz Pharma Italia","duties_or_roles":"Source of monetary support (listed under sourceOfMonetarySupport).","organisation_type":""}
• {"country":"","full_name":"MERZ PHARMACEUTICALS GMBH","duties_or_roles":"Marketing authorisation holder for the investigational medicinal product (productDictionaryInfo.nameOrg).","organisation_type":""}