Trial · NCT04873115
Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,
NCT04873115, Phase 4, Unknown, Proveca Pharma Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,. Trials, record NCT04873115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04873115
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,
- NCT number
- NCT04873115
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Proveca Pharma Limited
- Conditions
- Sialorrhea, Neurodevelopmental Disorders
- Interventions
- Placebo, Sialanar, Oral Rehabilitation
- First posted
- 2021-05-05
- Last updated
- 2022-07-08
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Drooling Impact Scale (DIS) between baseline and D84. | 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Change in Drooling Impact Scale (DIS) between baseline and D28. | 28 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Proportion of responders at D84 (a response is defined as a DIS improvement ≥ 13.6 points). | 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Proportion of responders at D28 (a response is defined as a DIS improvement ≥ 13.6 points). | 28 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Proportion of good responders at D84 (a good response is defined as a DIS improvement ≥ 28 points). | 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Secondary | Changes in the number of used bibs or clothing over 7 days (Item 3 of the DIS) at D84 | 84 days | |
| Secondary | Changes in the number of used bibs or clothing over 7 days (Item 3 of the DIS) at D28 | 28 days | |
| Other | Change in the DIS 10-point item 9 from baseline. "To what extent did your child's drooling affect his or her life?" to D28 and D84. | 28 and 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Other | Change in in the DIS 10-point item 10 from baseline. "To what extent did your child's dribbling affect you and your family's life?" to D28 and D84. | 28 and 84 days | DIS possible range is 10-100. Lower score indicates a better outcome. |
| Other | The change in DISABKIDS instrument from baseline to D84. | 84 days |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04873115
GET https://conductscience.org/api/trials/v1/NCT04873115/registered