Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

Sialorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06101160
• Other study ID #: BTX-S-JCP
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 30, 2023
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Juvenile cerebral palsy with age range (4 - 12 years)

• Having severe drooling (DFS > 4)

• Signing written informed consent by the legal guardians.

Exclusion Criteria:

• Previous BoNT-A injection in the last three months

• Patients receiving systemic medicine for the treatment of sialorrhea in the last 6 weeks

• Any contraindications to treatment with BoNT

Related Conditions & MeSH terms

• Cerebral Palsy
• Sialorrhea

Intervention

Drug:
• onaBoNT-A
injection under ultrasonography

Locations

Country	Name	City	State
Egypt	Hatem Shehata	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS)	Each patient was assigned a severity rank according to the following grades: 1, dry: never drools; 2, mild: only the lips are wet; 3, moderate: wet on the lips and chin; 4, severe: drools to the extent that clothing becomes damp; 5, profuse: clothing, hands, tray, and objects become wet. The frequency of drooling was also rated as 1, never drools; 2, occasional drooling; 3, frequent drooling; and 4, constant drooling. The final drooling score is the summed ranking across both scales together to make a combined drooling ranking from 2 to 9.	1 year