Trial · NCT00515437
A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
NCT00515437, Phase 2, Completed, Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC; results first posted 2009-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients. Trials, record NCT00515437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00515437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
- NCT number
- NCT00515437
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
- Conditions
- Drooling
- Interventions
- Botulinum Toxin Type B (Myobloc), Matched placebo to Myobloc
- First posted
- 2007-08-13
- Last updated
- 2026-04-21
- Results first posted
- 2009-08-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | baseline versus 4 weeks post-injection | 9 point scale, 0 = no drooling, 9 = severe drooling |
| Secondary | Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | baseline vs 12 weeks post injection | 9 point scale (0=no drooling, 9=severe drooling) |
| Secondary | Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection | baseline vs 4 weeks post-injection | saliva is collected over 5 minutes and weighed to produce a grams/minute "rate" |
| Secondary | Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection | baseline vs 12 weeks post-injection | saliva collected over 5 minutes and weighed to produce a grams/minute "rate" |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | baseline versus 4 weeks post-injection | Intent to Treat (ITT) | points on a scale | MEAN |
| SECONDARY | Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | baseline vs 12 weeks post injection | points on a scale | MEAN | |
| SECONDARY | Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection | baseline vs 4 weeks post-injection | grams/minute | MEAN | |
| SECONDARY | Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection | baseline vs 12 weeks post-injection | grams/minute | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | 1500U Myobloc | -2.1 | Standard Deviation 1.2 | points on a scale | |
| Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | 2500U Myobloc | -3.3 | Standard Deviation 1.4 | points on a scale | |
| Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | 3500U Myobloc | -3.5 | Standard Deviation 1.0 | points on a scale | |
| Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection | Placebo | -1.3 | Standard Deviation 1.3 | points on a scale | |
| Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | 1500U Myobloc | -1.9 | Standard Deviation 1.5 | points on a scale | |
| Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | 2500U Myobloc | -2.2 | Standard Deviation 1.6 | points on a scale | |
| Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | 3500U Myobloc | -2.2 | Standard Deviation 0.8 | points on a scale | |
| Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection | Placebo | -1.2 | Standard Deviation 1.3 | points on a scale | |
| Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection | 1500U Myobloc | -0.497 | Standard Deviation 0.38 | grams/minute | |
| Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection | 2500U Myobloc | -.381 | Standard Deviation 0.34 | grams/minute |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1500U Myobloc | 14 | |
| Overall Study | STARTED | 2500U Myobloc | 12 | |
| Overall Study | STARTED | 3500U Myobloc | 13 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | 1500U Myobloc | 14 | |
| Overall Study | COMPLETED | 2500U Myobloc | 12 | |
| Overall Study | COMPLETED | 3500U Myobloc | 13 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | 1500U Myobloc | 0 | |
| Overall Study | NOT COMPLETED | 2500U Myobloc | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
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 | Dry Mouth | Gastrointestinal disorders | 1500U Myobloc | 1 | 14 | 1 |
| other | Dry Mouth | Gastrointestinal disorders | 2500U Myobloc | 2 | 12 | 2 |
| other | Dry Mouth | Gastrointestinal disorders | 3500U Myobloc | 1 | 13 | 1 |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 0 | 15 | 0 |
| other | Breath Odor | Gastrointestinal disorders | 1500U Myobloc | 1 | 14 | 1 |
| other | Breath Odor | Gastrointestinal disorders | 2500U Myobloc | 2 | 12 | 2 |
| other | Breath Odor | Gastrointestinal disorders | 3500U Myobloc | 1 | 13 | 1 |
| other | Breath Odor | Gastrointestinal disorders | Placebo | 0 | 15 | 0 |
| other | Saliva Altered | Gastrointestinal disorders | 1500U Myobloc | 1 | 14 | 1 |
| other | Saliva Altered | Gastrointestinal disorders | 2500U Myobloc | 0 | 12 | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1500U Myobloc | ||
| Total, all-cause mortality | 2500U Myobloc | ||
| Total, all-cause mortality | 3500U Myobloc | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | 1500U Myobloc | 2 | |
| Total, other adverse events | 2500U Myobloc | 3 | |
| Total, other adverse events | 3500U Myobloc | 2 | |
| Total, other adverse events | Placebo | 1 | |
| Total, serious adverse events | 1500U Myobloc | 0 | |
| Total, serious adverse events | 2500U Myobloc | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00515437
GET https://conductscience.org/api/trials/v1/NCT00515437/events?page=2