Trial · NCT02610868
Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults
NCT02610868, Phase 3, Completed, Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC; results first posted 2019-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults. Trials, record NCT02610868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02610868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults
- NCT number
- NCT02610868
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
- Conditions
- Sialorrhea
- Interventions
- MYOBLOC
- First posted
- 2015-11-20
- Last updated
- 2026-04-21
- Results first posted
- 2019-11-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS) |
| Primary | Occurrence of Adverse Events of Special Interest (AESI) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia. |
| Primary | Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit. Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). |
| Primary | Occurrence of Dental Adverse Events | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Treatment Session (TS) |
| Secondary | Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4 | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. |
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. |
| Secondary | Clinical Global Impression of Change (CGI-C) | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. Treatment Session (TS) |
| Secondary | Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. The severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement. |
| Secondary | Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. The severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement. |
| Secondary | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U or 3000 U). | participants | NUMBER |
| PRIMARY | Occurrence of Adverse Events of Special Interest (AESI) | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | participants | NUMBER |
| PRIMARY | Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | participants | NUMBER | |
| PRIMARY | Occurrence of Dental Adverse Events | Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | participants | NUMBER |
| SECONDARY | Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4 | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | g/minute | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression of Change (CGI-C) | TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13 | Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U). | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 1 | Serious TEAEs | 7 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 2 | Serious TEAEs | 14 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 3 | Serious TEAEs | 3 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 4 | Serious TEAEs | 2 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 1 | Severe TEAEs | 5 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 2 | Severe TEAEs | 8 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 3 | Severe TEAEs | 2 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 4 | Severe TEAEs | 2 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 1 | TEAEs Related to Study Medication | 42 | participants | |
| Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) | Treatment Session 2 | TEAEs Related to Study Medication | 26 | participants |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| MYOBLOC: Treatment Session 1 | STARTED | MYOBLOC: 3500U | 187 | |
| MYOBLOC: Treatment Session 1 | COMPLETED | MYOBLOC: 3500U | 180 | |
| MYOBLOC: Treatment Session 1 | NOT COMPLETED | MYOBLOC: 3500U | 7 | |
| MYOBLOC: Treatment Session 2 | STARTED | MYOBLOC: 3500U | 177 | |
| MYOBLOC: Treatment Session 2 | COMPLETED | MYOBLOC: 3500U | 165 | |
| MYOBLOC: Treatment Session 2 | NOT COMPLETED | MYOBLOC: 3500U | 12 | |
| MYOBLOC: Treatment Session 3 | STARTED | MYOBLOC: 3500U | 50 | |
| MYOBLOC: Treatment Session 3 | COMPLETED | MYOBLOC: 3500U | 43 | |
| MYOBLOC: Treatment Session 3 | NOT COMPLETED | MYOBLOC: 3500U | 7 | |
| MYOBLOC: Treatment Session 4 | STARTED | MYOBLOC: 3500U | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events135
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dental caries | Gastrointestinal disorders | MYOBLOC: Treatment Session 1 | 13 | 187 | |
| other | Dental caries | Gastrointestinal disorders | MYOBLOC: Treatment Session 2 | 17 | 177 | |
| other | Dental caries | Gastrointestinal disorders | MYOBLOC: Treatment Session 3 | 6 | 50 | |
| other | Dental caries | Gastrointestinal disorders | MYOBLOC: Treatment Session 4 | 2 | 24 | |
| other | Dental caries | Gastrointestinal disorders | ALL MYOBLOC: Treatment Sessions 1-4 | 32 | 187 | |
| other | Dry mouth | Gastrointestinal disorders | MYOBLOC: Treatment Session 1 | 29 | 187 | |
| other | Dry mouth | Gastrointestinal disorders | MYOBLOC: Treatment Session 2 | 10 | 177 | |
| other | Dry mouth | Gastrointestinal disorders | MYOBLOC: Treatment Session 3 | 1 | 50 | |
| other | Dry mouth | Gastrointestinal disorders | MYOBLOC: Treatment Session 4 | 0 | 24 | |
| other | Dry mouth | Gastrointestinal disorders | ALL MYOBLOC: Treatment Sessions 1-4 | 33 | 187 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MYOBLOC: Treatment Session 1 | 1 | 187 |
| Total, all-cause mortality | MYOBLOC: Treatment Session 2 | 4 | 177 |
| Total, all-cause mortality | MYOBLOC: Treatment Session 3 | 2 | 50 |
| Total, all-cause mortality | MYOBLOC: Treatment Session 4 | 1 | 24 |
| Total, all-cause mortality | ALL MYOBLOC: Treatment Sessions 1-4 | 8 | 187 |
| Total, other adverse events | MYOBLOC: Treatment Session 1 | 44 | 187 |
| Total, other adverse events | MYOBLOC: Treatment Session 2 | 34 | 177 |
| Total, other adverse events | MYOBLOC: Treatment Session 3 | 7 | 50 |
| Total, other adverse events | MYOBLOC: Treatment Session 4 | 4 | 24 |
| Total, other adverse events | ALL MYOBLOC: Treatment Sessions 1-4 | 73 | 187 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40498248 | DERIVED |
Source PubMed
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/NCT02610868
GET https://conductscience.org/api/trials/v1/NCT02610868/results?page=2