Trial · NCT01994109
Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
NCT01994109, Phase 3, Completed, Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC; results first posted 2019-08-15
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 Adult Subjects. Trials, record NCT01994109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01994109
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 Adult Subjects
- NCT number
- NCT01994109
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
- Conditions
- Sialorrhea
- Interventions
- MYOBLOC, PLACEBO
- First posted
- 2013-11-25
- Last updated
- 2026-04-21
- Results first posted
- 2019-08-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) | 4 Weeks | Change weight of expectorated saliva at a Week 4 post-injection visit. |
| Primary | Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) | 4 weeks | CGI-C was assessed on a 7-point scale ranging from "very much improved" to "very much worse" with 1 assigned to "very much improved" and 7 assigned to "very much worse"; ranging from a minimum score of 1 and a maximum score of 7. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) | 4 Weeks | The per protocol included subjects with a minimum USFR of 0.2 g/min. | g/minute | LEAST_SQUARES_MEAN |
| PRIMARY | Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) | 4 weeks | Per protocol the intent-to-treat population who were injected with study medication and had at least 1 post injection CGI-C measurement up to week 4 (inclusive). | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) | MYOBLOC 2500 U | -0.37 | Standard Error 0.03 | g/minute | |
| Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) | MYOBLOC 3500 U | -0.36 | Standard Error 0.03 | g/minute | |
| Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A) | Placebo | -0.07 | Standard Error 0.03 | g/minute | |
| Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) | MYOBLOC 2500 U | 2.38 | Standard Error 0.12 | score on a scale | |
| Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) | MYOBLOC 3500 U | 2.45 | Standard Error 0.12 | score on a scale | |
| Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A) | Placebo | 3.59 | Standard Error 0.13 | score on a scale |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase (Part A) | STARTED | DB: MYOBLOC 2500 U | 63 | |
| Double-blind Phase (Part A) | STARTED | DB: MYOBLOC 3500 U | 64 | |
| Double-blind Phase (Part A) | STARTED | DB: Placebo | 60 | |
| Double-blind Phase (Part A) | STARTED | OL: ALL MYOBLOC | 0 | |
| Double-blind Phase (Part A) | COMPLETED | DB: MYOBLOC 2500 U | 62 | |
| Double-blind Phase (Part A) | COMPLETED | DB: MYOBLOC 3500 U | 61 | |
| Double-blind Phase (Part A) | COMPLETED | DB: Placebo | 53 | |
| Double-blind Phase (Part A) | COMPLETED | OL: ALL MYOBLOC | 0 | |
| Double-blind Phase (Part A) | NOT COMPLETED | DB: MYOBLOC 2500 U | 1 | |
| Double-blind Phase (Part A) | NOT COMPLETED | DB: MYOBLOC 3500 U | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events236
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 2500 U (Part A) | 5 | 63 | |
| other | Dental caries | Gastrointestinal disorders | MYOBLOC 3500 U (Part A) | 3 | 64 | |
| other | Dental caries | Gastrointestinal disorders | Placebo (Part A) | 2 | 60 | |
| other | Dental caries | Gastrointestinal disorders | OL: ALL MYOBLOC (Part B) | 50 | 170 | |
| other | Dry mouth | Gastrointestinal disorders | MYOBLOC 2500 U (Part A) | 24 | 63 | |
| other | Dry mouth | Gastrointestinal disorders | MYOBLOC 3500 U (Part A) | 29 | 64 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo (Part A) | 5 | 60 | |
| other | Dry mouth | Gastrointestinal disorders | OL: ALL MYOBLOC (Part B) | 73 | 170 | |
| other | Dysphagia | Gastrointestinal disorders | MYOBLOC 2500 U (Part A) | 7 | 63 | |
| other | Dysphagia | Gastrointestinal disorders | MYOBLOC 3500 U (Part A) | 3 | 64 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MYOBLOC 2500 U (Part A) | 0 | 63 |
| Total, all-cause mortality | MYOBLOC 3500 U (Part A) | 2 | 64 |
| Total, all-cause mortality | Placebo (Part A) | 1 | 60 |
| Total, all-cause mortality | OL: ALL MYOBLOC (Part B) | 9 | 170 |
| Total, other adverse events | MYOBLOC 2500 U (Part A) | 44 | 63 |
| Total, other adverse events | MYOBLOC 3500 U (Part A) | 38 | 64 |
| Total, other adverse events | Placebo (Part A) | 16 | 60 |
| Total, other adverse events | OL: ALL MYOBLOC (Part B) | 143 | 170 |
| Total, serious adverse events | MYOBLOC 2500 U (Part A) | 1 | 63 |
| Total, serious adverse events | MYOBLOC 3500 U (Part A) | 4 | 64 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01994109
GET https://conductscience.org/api/trials/v1/NCT01994109/flow?page=2