NCT06101160

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 20, 2023

Last Update Submit

October 25, 2023

Conditions

Sialorrhea

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

onaBoNT-ADRUG

injection under ultrasonography

Also known as: Botox

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Juvenile CP patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatem Shehata

Cairo, 11256, Egypt

Location

MeSH Terms

Conditions

Sialorrhea

Interventions

onabotulinum toxin ABotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 26, 2023

Study Start

June 30, 2021

Primary Completion

May 1, 2022

Study Completion

April 30, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

EG(1)