Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy
NCT ID: NCT06101160
Last Updated: 2023-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
61 participants
OBSERVATIONAL
2021-06-30
2023-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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onaBoNT-A
injection under ultrasonography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having severe drooling (DFS \> 4)
* Signing written informed consent by the legal guardians.
Exclusion Criteria
* Patients receiving systemic medicine for the treatment of sialorrhea in the last 6 weeks
* Any contraindications to treatment with BoNT
4 Years
12 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Hatem Samir Shehata
Professor of Neurology
Locations
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Hatem Shehata
Cairo, , Egypt
Countries
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Other Identifiers
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BTX-S-JCP
Identifier Type: -
Identifier Source: org_study_id
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