Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

Completed

• Conditions: Sialorrhea

• Registration Number: NCT06101160
• Lead Sponsor: Cairo University

Brief 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

Study Timeline

• Study Start: 2021-06-30
• Primary Completion: 2022-05-01
• Study Completion: 2023-04-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Juvenile cerebral palsy with age range (4 - 12 years)
• Having severe drooling (DFS > 4)
• Signing written informed consent by the legal guardians.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS)	1 year	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.

Trial Locations

Locations (1)

Hatem Shehata; 🇪🇬 Cairo, Egypt