Trial · NCT00761137
Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
NCT00761137, Phase 2, Completed, NeuroHealing Pharmaceuticals Inc.; results first posted 2015-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients. Trials, record NCT00761137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
- NCT number
- NCT00761137
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- NeuroHealing Pharmaceuticals Inc.
- Conditions
- Sialorrhea Secondary to Parkinson's Disease
- Interventions
- 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide
- First posted
- 2008-09-29
- Last updated
- 2015-10-12
- Results first posted
- 2015-10-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sialorrhea Visual Analogue Scale (VAS) | Before and 120 min after treatment administration | Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels. |
| Secondary | Percentage Change in Saliva Volume | Before and 75 minutes after treatment administration | Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined. |
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 | Sialorrhea Visual Analogue Scale (VAS) | Before and 120 min after treatment administration | cm on VAS | MEAN | |
| SECONDARY | Percentage Change in Saliva Volume | Before and 75 minutes after treatment administration | Percentage saliva volume change was determined in the last seven (7) patients enrolled. | percentage change of saliva volume | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sialorrhea Visual Analogue Scale (VAS) | Tropicamide - Placebo | -0.55 | Standard Deviation 0.54 | cm on VAS | |
| Sialorrhea Visual Analogue Scale (VAS) | Tropicamide - 0.3 mg | -1.08 | Standard Deviation 0.54 | cm on VAS | |
| Sialorrhea Visual Analogue Scale (VAS) | Tropicamide - 1 mg | -1.53 | Standard Deviation 0.52 | cm on VAS | |
| Sialorrhea Visual Analogue Scale (VAS) | Tropicamide 3 mg | -0.81 | Standard Deviation 0.51 | cm on VAS | |
| Percentage Change in Saliva Volume | Tropicamide - Placebo | -5 | 95% Confidence Interval -27 to 17 | percentage change of saliva volume | |
| Percentage Change in Saliva Volume | Tropicamide - 0.3 mg | -27 | 95% Confidence Interval -48 to -6 | percentage change of saliva volume | |
| Percentage Change in Saliva Volume | Tropicamide - 1 mg | -33 | 95% Confidence Interval -60 to -7 | percentage change of saliva volume | |
| Percentage Change in Saliva Volume | Tropicamide 3 mg | -20 | 95% Confidence Interval -33 to -7 | percentage change of saliva volume |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 19 | |
| Overall Study | Placebo | All Participants | 19 | |
| Overall Study | 0.3 mg Tropicamide | All Participants | 19 | |
| Overall Study | 1 mg Tropicamide | All Participants | 19 | |
| Overall Study | 3 mg Tropicamide | All Participants | 19 | |
| Overall Study | COMPLETED | All Participants | 19 | |
| Overall Study | NOT COMPLETED | All Participants | 0 |
Source ClinicalTrials.gov
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 0 | 19 |
| Total, serious adverse events | All Participants | 0 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21636098 | RESULT |
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/NCT00761137
GET https://conductscience.org/api/trials/v1/NCT00761137/registered