Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT06101160

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sialorrhea	Drug: onaBoNT-A

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 30, 2021

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

Apr 30, 2023

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 12 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hatem Shehata	Cairo		Egypt	11256

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hatem Samir Shehata, Professor of Neurology, Cairo University

ClinicalTrials.gov Identifier:

NCT06101160

Other Study ID Numbers:

BTX-S-JCP

First Posted:

Oct 26, 2023

Last Update Posted:

Oct 27, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sialorrhea

Cerebral Palsy

Study Results

No Results Posted as of Oct 27, 2023