Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06150729

Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy

Sponsor: AbbVie

View on ClinicalTrials.gov

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