Trial · NCT02091739
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
NCT02091739, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2018-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions. Trials, record NCT02091739. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02091739
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
- NCT number
- NCT02091739
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 184 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Chronic Troublesome Sialorrhea, Parkinson's Disease, Post-stroke, Traumatic Brain Injury
- Interventions
- IncobotulinumtoxinA (100 Units), IncobotulinumtoxinA (75 Units), Placebo
- First posted
- 2014-03-19
- Last updated
- 2018-03-27
- Other registries' IDs
- eudract:2012-005539-10
- Results first posted
- 2018-02-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 | Baseline and Week 4 | uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated. |
| Primary | MP: Participant's Global Impression of Change Scale (GICS) at Week 4 | Week 4 | The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank. |
| Secondary | MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 | Baseline, Week 8 and 12 | uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated. |
| Secondary | MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12 | Week 1, 2, 8, and 12 | The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank. |
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 | MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 | Baseline and Week 4 | Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR. | gram per minute (g/min) | LEAST_SQUARES_MEAN |
| PRIMARY | MP: Participant's Global Impression of Change Scale (GICS) at Week 4 | Week 4 | The FAS is the subset of participants who were treated and had at least the baseline value of uSFR. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 | Baseline, Week 8 and 12 | Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR. | g/min | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12 | Week 1, 2, 8, and 12 | The FAS is the subset of participants who were treated and had at least the baseline value of uSFR. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 | MP: Placebo | -0.04 | Standard Error 0.033 | gram per minute (g/min) | |
| MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | -0.06 | Standard Error 0.027 | gram per minute (g/min) | |
| MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | -0.13 | Standard Error 0.026 | gram per minute (g/min) | |
| MP: Participant's Global Impression of Change Scale (GICS) at Week 4 | MP: Placebo | 0.67 | Standard Error 0.186 | units on a scale | |
| MP: Participant's Global Impression of Change Scale (GICS) at Week 4 | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | 1.02 | Standard Error 0.148 | units on a scale | |
| MP: Participant's Global Impression of Change Scale (GICS) at Week 4 | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | 1.25 | Standard Error 0.144 | units on a scale | |
| MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 | MP: Placebo | Week 8 | -0.02 | Standard Error 0.033 | g/min |
| MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | Week 8 | -0.08 | Standard Error 0.027 | g/min |
| MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | Week 8 | -0.13 | Standard Error 0.026 | g/min |
| MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 | MP: Placebo | Week 12 | -0.03 | Standard Error 0.033 | g/min |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| MP: 16 Weeks | STARTED | Placebo | 36 | |
| MP: 16 Weeks | STARTED | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | 74 | |
| MP: 16 Weeks | STARTED | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | 74 | |
| MP: 16 Weeks | STARTED | EP: IncobotulinumtoxinA (Xeomin) (75 Units) | 0 | |
| MP: 16 Weeks | STARTED | EP: IncobotulinumtoxinA (Xeomin) (100 Units) | 0 | |
| MP: 16 Weeks | COMPLETED | Placebo | 32 | |
| MP: 16 Weeks | COMPLETED | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | 69 | |
| MP: 16 Weeks | COMPLETED | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | 72 | |
| MP: 16 Weeks | COMPLETED | EP: IncobotulinumtoxinA (Xeomin) (75 Units) | 0 | |
| MP: 16 Weeks | COMPLETED | EP: IncobotulinumtoxinA (Xeomin) (100 Units) | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events475
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 | Hypertension | Vascular disorders | Placebo | 1 | 36 | 1 |
| other | Hypertension | Vascular disorders | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | 2 | 74 | 2 |
| other | Hypertension | Vascular disorders | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | 3 | 74 | 3 |
| other | Hypertension | Vascular disorders | EP: IncobotulinumtoxinA (Xeomin) (75 Units) | 5 | 82 | 5 |
| other | Hypertension | Vascular disorders | EP: IncobotulinumtoxinA (Xeomin) (100 Units) | 2 | 89 | 2 |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 0 | 36 | 0 |
| other | Fall | Injury, poisoning and procedural complications | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | 6 | 74 | 8 |
| other | Fall | Injury, poisoning and procedural complications | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | 2 | 74 | 5 |
| other | Fall | Injury, poisoning and procedural complications | EP: IncobotulinumtoxinA (Xeomin) (75 Units) | 5 | 82 | 9 |
| other | Fall | Injury, poisoning and procedural complications | EP: IncobotulinumtoxinA (Xeomin) (100 Units) | 4 | 89 | 5 |
1 to 10 of 475Source ClinicalTrials.gov
See all 475 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 36 |
| Total, all-cause mortality | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | 0 | 74 |
| Total, all-cause mortality | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | 0 | 74 |
| Total, all-cause mortality | EP: IncobotulinumtoxinA (Xeomin) (75 Units) | 3 | 82 |
| Total, all-cause mortality | EP: IncobotulinumtoxinA (Xeomin) (100 Units) | 2 | 89 |
| Total, other adverse events | Placebo | 2 | 36 |
| Total, other adverse events | MP: IncobotulinumtoxinA (Xeomin) (75 Units) | 14 | 74 |
| Total, other adverse events | MP: IncobotulinumtoxinA (Xeomin) (100 Units) | 10 | 74 |
| Total, other adverse events | EP: IncobotulinumtoxinA (Xeomin) (75 Units) | 22 | 82 |
| Total, other adverse events | EP: IncobotulinumtoxinA (Xeomin) (100 Units) | 22 | 89 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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/NCT02091739
GET https://conductscience.org/api/trials/v1/NCT02091739/results?page=2