NCT06101160

Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

Long-term Follow-up of Safety and Efficacy of OnabotulinumtoxinA for Treatment of Sialorrhea in Juvenile Cerebral Palsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: —

Summary

A 100 units of botulinum toxin was injected in both parotid and submandibular glands for children (2 - 12 years) with incapacitating sialorrhea in juvenile cerebral palsy patients and they are followed up for 1 year

Detailed description

This was a prospective, longitudinal analysis with 1-year follow-up of 52 children with juvenile cerebral palsy (JCP) suffering from sialorrhea enrolled from 3 tertiary pediatric neurology rehabilitation centers (two in Cairo and one in Alexandria) and subjected to repeated BoNT-A injection. The recruitment period was between June 30, 2021, until May 1, 2022 (the last patient follow-up ended on April 30, 2023). Intervention: 100 units of OnabotulinumtoxinA (Botox®) were injected in the parotid and submandibular glands Follow-up visits: mo 1 post-injection (for every injection session) and every 3 months thereafter In each visit; the following efficacy variables were assessed: Primary outcome measures: The severity and frequency of sialorrhea evaluated by Drooling Severity Scale (DSS), and Drooling Frequency Scale (DFS) and visual-analogic ratings of familial distress (VAS-FD). Secondary outcome measure: The carers' Global Impression of Change Scale score measured on a 7-point Likert scale from -3 (very much worse) to +3 (very much improved) Also, adverse events were assessed in each visit

Conditions

• Sialorrhea

Interventions

Type	Name	Description
DRUG	onaBoNT-A	injection under ultrasonography

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-05-01
• Completion: 2023-04-30
• First posted: 2023-10-26
• Last updated: 2023-10-27

Locations

1 site across 1 country: Egypt