SialorrheaNCT06101160
Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy
An observational study of Sialorrhea, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Sialorrhea
- What is being tested?
- onaBoNT-A
- Type of treatment
- Injection or infusion
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2021to 30 Apr 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Child
Study population: Juvenile CP patients
Who may be able to join
- Juvenile cerebral palsy with age range (4 - 12 years)
- Having severe drooling (DFS > 4)
- Signing written informed consent by the legal guardians.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of Safety and Efficacy of OnabotulinumtoxinA for Treatment of Sialorrhea in Juvenile 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
Read the 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
- Conditions
- Sialorrhea
- Being tested
- onaBoNT-A
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onaBoNT-ADrug
Also called Botox
injection under ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start30 Jun 2021
- Primary completion1 May 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SialorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Samir Shehata, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101160
- Sponsor's protocol ID
- BTX-S-JCP
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Safety and Efficacy of OnabotulinumtoxinA for Treatment of Sialorrhea in Juvenile Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06101160
- Acronym / sponsor ID
- BTX-S-JCP
- Conditions
- Sialorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Juvenile CP patients
Key inclusion criteria (3 listed)
- Juvenile cerebral palsy with age range (4 - 12 years)
- Having severe drooling (DFS > 4)
- Signing written informed consent by the legal guardians.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| onaBoNT-AAlso: Botoxinjection under ultrasonography | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sialorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.