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Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
Sponsor: AbbVie
Summary
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated. OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico. Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.
Official title: Botulinum A Toxin (OnabotulinumtoxinA) Use in Mexican Pediatric Population With Spasticity Associated With Cerebral Palsy: Phase IV, Observational, Non-Interventional, Prospective, Multicenter Study
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
OBSERVATIONAL
Enrollment
107
Start Date
2023-09-08
Completion Date
2025-05-30
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Locations (8)
Hospital General Regional 180 IMSS /ID# 261458
Guadalajara, Jalisco, Mexico
Clinica de Rehabilitacion Integral Yupi /Id# 261461
Puerto Vallarta, Jalisco, Mexico
Hospital General ISSSTE Tacuba /ID# 261460
Mexico City, Mexico City, Mexico
Hospital General ISSSTE Tacuba /ID# 261932
Mexico City, Mexico City, Mexico
Cree Dif Nuevo Leon /Id# 261454
Monterrey, Nuevo LEON, Nuevo León, Mexico
Hospital Militar De Zona De Villahermosa /ID# 261451
Villahermosa, Tabasco, Mexico
Cri Dif Jalisco /Id# 261459
Guadalajara, Mexico
Crit Estado de México /Id# 261934
Tlalnepantla, Mexico