Trial · NCT05097079
Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects
NCT05097079, Phase 3, Withdrawn, Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects. Trials, record NCT05097079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05097079
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects
- NCT number
- NCT05097079
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
- Conditions
- Sialorrhea
- Interventions
- MYOBLOC Low Dose, MYOBLOC High Dose, Placebo
- First posted
- 2021-10-27
- Last updated
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The change from baseline in the Unstimulated Saliva Flow Rate (USFR) at Week 4 post-injection. | Baseline and Week 4 | At each study visit, the subject's saliva is collected for at least 3 minutes and weighed (grams). The Unstimulated Saliva Flow Rate (USFR; grams/minute) for each visit is calculated for by dividing the 'total grams of saliva collected during the collection period' by the 'total minutes of the collection period. The USFR at Week 4 post-injection visit subtracted from the USFR at Baseline visit (prior to injection) yields the change from baseline USFR. A change from baseline USFR \<0 grams/minutes represents a better outcome. |
| Primary | The Clinical Global Impression of Change (CGI-C) score at Week 4 post-injection. | Week 4 | The Clinical Global Impression of Change (CGI-C) scale is a single item clinician assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The CGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score \<4 represents a better outcome. |
| Secondary | The Parent/Guardian Global Impression of Change (PGI-C) score at Week 4 post-injection. | Week 4 | The Parent/Guardian Global Impression of Change (PGI-C) scale is a single item parent/guardian assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The PGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A PGI-C score \<4 represents a better outcome |
| Secondary | The change from baseline in the Unstimulated Saliva Flow Rate (USFR) at Weeks 2, 8 and 13 post-injection. | Baseline and Weeks 2, 8 and 13 | At each study visit, the subject's saliva is collected for at least 3 minutes and weighed (grams). The Unstimulated Saliva Flow Rate (USFR; grams/minute) for each visit is calculated for by dividing the 'total grams of saliva collected during the collection period' by the 'total minutes of the collection period'. The USFR at the post-injection visit subtracted from the USFR at Baseline visit (prior to injection) yields the change from baseline USFR. A change from baseline USFR \<0 grams/minutes represents a better outcome. |
| Secondary | The Clinical Global Impression of Change (CGI-C) score at Weeks 2, 8, and 13 post-injection. | Weeks 2, 8 and 13 | The Clinical Global Impression of Change (CGI-C) scale is a single item clinician assessment of how much the subject's the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The CGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score \<4 represents a better outcome. |
| Secondary | The Parent/Guardian Global Impression of Change (PGI-C) score at Week 2, 8, and 13 post-injection. | Weeks 2, 8, and 13 | The Parent/Guardian Global Impression of Change (PGI-C) scale is a single item parent/guardian assessment of how much the subject's condition (sialorrhea) has improved, worsened or has not changed relative to subject's state at baseline prior to treatment (injection). The PGI-C is rated on a 7-point scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A PGI-C score \<4 represents a better outcome. |
| Secondary | The change from baseline in the Modified Teacher's Drooling Scale (mTDS) score at Week4 post injection. | Baseline and Week 4 | The Modified Teacher's Drooling Scale (mTDS) is a single-item scale used to assess subject's drooling severity and frequency. It is rated by the parent/guardian on a 9-point scale (1-9); where 1 = "Dry: never drools"; 2 = "Mild: only the lips are wet, occasionally"; 3 = "Mild: only the lips are wet, frequently"; 4 = "Moderate: wet on the lips and chin, occasionally"; 5 = "Moderate: wet on the lips and chin, frequently"; 6 = "Severe: drools to the extent that clothing becomes damp, occasionally"; 7 = "Severe: drools to the extent that clothing becomes damp, frequently"; 8 = "Profuse: clothing, hands, tray, and objects become wet, occasionally"; 9 = "Profuse: clothing, hands, tray, and objects become wet, frequently". The mTDS score at Week 4 Post injection subtracted from the mTDS score at Baseline yields the change from baseline mTDS score. A change from baseline mTDS score \<0 represents a better outcome. |
| Secondary | The change from baseline in the Drooling Impact Scale (DIS) score at Week 4 post-injection. | Baseline and Week 4 | The Drooling Impact Scale (DIS) is a 10-item questionnaire used to assess the frequency, severity, and impact of subject's drooling. Each item is rated by the parent/guardian on a 10-point end-anchor semantic differential scale (1 to 10; where 1 = "best outcome" to 10 = "worst outcome"). The sum of all 10 items yields a total score (ranging from 10-100). The DIS total score at Week 4 Post injection subtracted from the DIS total score at Baseline yields the change from baseline DIS total score. A change from baseline DIS score \<0 represents a better outcome. |
Source ClinicalTrials.gov
Outcomes0
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/NCT05097079
GET https://conductscience.org/api/trials/v1/NCT05097079/registered