BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX for Spastic equinovarus (post-stroke) | First-ever unilateral stroke

Inclusion criteria

• {"criterion_text":"- Participants eligible for inclusion in this Trial must meet all of the following criteria\n- 1.\tVoluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n- 2.\tAt least 18 years of age at the time of signing the Informed Consent Form (ICF)\n- 3.\tUse of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n- 4.\tPes equinovarus due to spasticity\n- 5.\tClinical need for BoNT injection at the lower leg\n- 6.\tAny previous injection of BoNT into the muscles to be investigated was at least 3 months ago\n- 7.\tFirst-ever, unilateral stroke"}

Exclusion criteria

• {"criterion_text":"- 1.\tMusculoskeletal or other neurological problems affecting the lower limb\n- 2.\tPresence of spinal cord pathology that could lead to spasticity, ataxia, dystonia\n- 3.\tCognitive problems that impede measurements\n- 4.\tSevere co-morbidities\n- 5.\tIrritated skin or open wounds where ultrasound will be placed\n- 6.\tPregnancy\n- 7.\tProfound atrophy of the muscles in the target area(s) of injection"}

Primary endpoints

• {"endpoint_text":"- 1) Primary outcome parameters measured by 3DfUS muscle volume.","definition_or_measurement_approach":"Measured by Three Dimensional freehand Ultrasound (3DfUS) to assess muscle volume."}
• {"endpoint_text":"- 2) Primary outcome parameters measured by ISA The primary outcome parameter to determine the neural contributions to hyperresistance will be derived from the fast stretch: muscle activity (root mean square (RMS) EMG [uV].","definition_or_measurement_approach":"Measured by Instrumented Spasticity Assessment (ISA); neural contribution derived from fast stretch quantified as muscle activity (root mean square (RMS) EMG in µV)."}

Belgium

Earliest CTIS Part Ii Submission Date

26-11-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

6

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium