NCT06150729

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

Botulinum A Toxin (OnabotulinumtoxinA) Use in Mexican Pediatric Population With Spasticity Associated With Cerebral Palsy: Phase IV, Observational, Non-Interventional, Prospective, Multicenter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 107 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spasticity

Timeline

• Start date: 2023-09-08
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-11-29
• Last updated: 2025-07-02

Locations

8 sites across 1 country: Mexico