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Completed

NCT Number: NCT06101160

Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

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

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Key information

Conditions

Sialorrhea Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hatem Shehata

Cairo, 11256, Egypt

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

onaBoNT-A

Drug

injection under ultrasonography

Other names: Botox

Primary outcomes

  1. Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 26, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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