Trial · NCT02270736
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
NCT02270736, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2021-01-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability. Trials, record NCT02270736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02270736
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
- NCT number
- NCT02270736
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 256 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Chronic Troublesome Sialorrhea, Cerebral Palsy, Stroke, Traumatic Brain Injury, Intellectual Disability
- Interventions
- NT 201 Placebo, NT 201
- First posted
- 2014-10-21
- Last updated
- 2021-08-10
- Other registries' IDs
- eudract:2013-004532-30
- Results first posted
- 2021-01-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4 | Baseline and Week 4 | This endpoint was planned to be analyzed in double-blind, MP, 6 to 17 years participants only. uSFR was assessed by weighing of absorbent swabs with safety threads soaked with saliva over 5 minutes and the procedure was repeated after 30 minutes. Salivary flow rate was equal to weight increase of swabs/time of collection. The average of the 2 results for flow rate was calculated. The reduction of measured weight over the study relates to improvement of sialorrhea. |
| Primary | Global Impression of Change Scale (GICS) at Week 4 Assessed by the Carer/Parent(s) | Week 4 | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. The GICS was used to measure the carer's/parent's impression of change due to treatment. The response option was a common 7-point Likert scale, with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). |
| Primary | Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | Baseline up to Week 64 | |
| Secondary | Change From Baseline in uSFR at Weeks 8 and 12 | Baseline and Weeks 8 and 12 | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. uSFR was assessed by weighing of absorbent swabs with safety threads soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes. Salivary flow rate was equal to weight increase of swabs/time of collection. The average of the 2 results for flow rate was calculated. The reduction of measured weight over the study relates to improvement of sialorrhea. |
| Secondary | GICS at Weeks 8 and 12 | Weeks 8 and 12 | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. The GICS was used to measure the carer's/parent's impression of change due to treatment. The response option was a common 7-point Likert scale with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). |
| Secondary | Occurrence of Treatment Emergent Adverse Events of Special Interest (AESI) Overall and by Injection Cycle | Baseline up to Week 64 | |
| Secondary | Occurrence of Treatment Emergent Serious Adverse Events (TESAEs) Overall and by Injection Cycle | Baseline up to Week 64 | |
| Secondary | Occurrence of TEAEs Related to Treatment as Assessed by the Investigator Overall and by Injection Cycle | Baseline up to Week 64 | |
| Secondary | Occurrence of TEAEs Leading to Discontinuation Overall and by Injection Cycle | Baseline up to Week 64 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4 | Baseline and Week 4 | The full analysis set (FAS) is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | gram per minute (g/min) | LEAST_SQUARES_MEAN |
| PRIMARY | Global Impression of Change Scale (GICS) at Week 4 Assessed by the Carer/Parent(s) | Week 4 | The FAS is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | Baseline up to Week 64 | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. n is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in uSFR at Weeks 8 and 12 | Baseline and Weeks 8 and 12 | The FAS is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | g/min | LEAST_SQUARES_MEAN |
| SECONDARY | GICS at Weeks 8 and 12 | Weeks 8 and 12 | The FAS is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Occurrence of Treatment Emergent Adverse Events of Special Interest (AESI) Overall and by Injection Cycle | Baseline up to Week 64 | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. n is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of Treatment Emergent Serious Adverse Events (TESAEs) Overall and by Injection Cycle | Baseline up to Week 64 | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. n is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of TEAEs Related to Treatment as Assessed by the Investigator Overall and by Injection Cycle | Baseline up to Week 64 | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. n is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurrence of TEAEs Leading to Discontinuation Overall and by Injection Cycle | Baseline up to Week 64 | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. n is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4 | Double-blind MP: Placebo (Age 6 to 17 Years) | -0.07 | Standard Error 0.015 | gram per minute (g/min) | |
| Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4 | Double-blind, MP: NT 201 (Age 6 to 17 Years) | -0.14 | Standard Error 0.012 | gram per minute (g/min) | |
| Global Impression of Change Scale (GICS) at Week 4 Assessed by the Carer/Parent(s) | Double-blind MP: Placebo (Age 6 to 17 Years) | 0.63 | Standard Error 0.104 | units on a scale | |
| Global Impression of Change Scale (GICS) at Week 4 Assessed by the Carer/Parent(s) | Double-blind, MP: NT 201 (Age 6 to 17 Years) | 0.91 | Standard Error 0.075 | units on a scale | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | Double-blind MP: Placebo (Age 6 to 17 Years) | Overall | 11 | Participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | Double-blind, MP: NT 201 (Age 6 to 17 Years) | Overall | 27 | Participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | Open-label, MP: NT 201 (Age 2 to 5 Years) | Overall | 5 | Participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | OLEX: NT 201 (Age 6 to 17 Years) | Overall | 92 | Participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | OLEX: NT 201 (Age 2 to 5 Years) | Overall | 15 | Participants | |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | Double-blind MP: Placebo (Age 6 to 17 Years) | First injection cycle (MP) | 11 | Participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Period (MP) (up to 16 Weeks) | STARTED | Double-blind MP: Placebo (Age 6 to 17 Years) | 72 | |
| Main Period (MP) (up to 16 Weeks) | STARTED | Double-blind, MP: NT 201 (Age 6 to 17 Years) | 148 | |
| Main Period (MP) (up to 16 Weeks) | STARTED | Open-label, MP: NT 201 (Age 2 to 5 Years) | 36 | |
| Main Period (MP) (up to 16 Weeks) | STARTED | OLEX: NT 201 (Age 6 to 17 Years) | 0 | |
| Main Period (MP) (up to 16 Weeks) | STARTED | OLEX: NT 201 (Age 2 to 5 Years) | 0 | |
| Main Period (MP) (up to 16 Weeks) | Treated | Double-blind MP: Placebo (Age 6 to 17 Years) | 72 | |
| Main Period (MP) (up to 16 Weeks) | Treated | Double-blind, MP: NT 201 (Age 6 to 17 Years) | 148 | |
| Main Period (MP) (up to 16 Weeks) | Treated | Open-label, MP: NT 201 (Age 2 to 5 Years) | 35 | |
| Main Period (MP) (up to 16 Weeks) | Treated | OLEX: NT 201 (Age 6 to 17 Years) | 0 | |
| Main Period (MP) (up to 16 Weeks) | Treated | OLEX: NT 201 (Age 2 to 5 Years) | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events110
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 | Nasopharyngitis | Infections and infestations | Double-blind MP: Placebo (Age 6 to 17 Years) | 3 | 72 | 3 |
| other | Nasopharyngitis | Infections and infestations | Double-blind, MP: NT 201 (Age 6 to 17 Years) | 3 | 148 | 3 |
| other | Nasopharyngitis | Infections and infestations | Open-label, MP: NT 201 (Age 2 to 5 Years) | 2 | 35 | 3 |
| other | Nasopharyngitis | Infections and infestations | OLEX: NT 201 (Age 6 to 17 Years) | 13 | 214 | 16 |
| other | Nasopharyngitis | Infections and infestations | OLEX: NT 201 (Age 2 to 5 Years) | 1 | 33 | 1 |
| other | Pharyngitis | Infections and infestations | Double-blind MP: Placebo (Age 6 to 17 Years) | 0 | 72 | 0 |
| other | Pharyngitis | Infections and infestations | Double-blind, MP: NT 201 (Age 6 to 17 Years) | 0 | 148 | 0 |
| other | Pharyngitis | Infections and infestations | Open-label, MP: NT 201 (Age 2 to 5 Years) | 0 | 35 | 0 |
| other | Pharyngitis | Infections and infestations | OLEX: NT 201 (Age 6 to 17 Years) | 12 | 214 | 13 |
| other | Pharyngitis | Infections and infestations | OLEX: NT 201 (Age 2 to 5 Years) | 3 | 33 | 3 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind MP: Placebo (Age 6 to 17 Years) | 0 | 72 |
| Total, all-cause mortality | Double-blind, MP: NT 201 (Age 6 to 17 Years) | 0 | 148 |
| Total, all-cause mortality | Open-label, MP: NT 201 (Age 2 to 5 Years) | 0 | 35 |
| Total, all-cause mortality | OLEX: NT 201 (Age 6 to 17 Years) | 0 | 214 |
| Total, all-cause mortality | OLEX: NT 201 (Age 2 to 5 Years) | 0 | 33 |
| Total, other adverse events | Double-blind MP: Placebo (Age 6 to 17 Years) | 3 | 72 |
| Total, other adverse events | Double-blind, MP: NT 201 (Age 6 to 17 Years) | 3 | 148 |
| Total, other adverse events | Open-label, MP: NT 201 (Age 2 to 5 Years) | 2 | 35 |
| Total, other adverse events | OLEX: NT 201 (Age 6 to 17 Years) | 34 | 214 |
| Total, other adverse events | OLEX: NT 201 (Age 2 to 5 Years) | 12 | 33 |
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/NCT02270736
GET https://conductscience.org/api/trials/v1/NCT02270736/results?page=2