Trial · NCT02708186
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
NCT02708186, Phase 2, Completed, Axovant Sciences Ltd.; results first posted 2020-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD). Trials, record NCT02708186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02708186
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
- NCT number
- NCT02708186
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Axovant Sciences Ltd.
- Conditions
- Dementia With Lewy Bodies, REM Sleep Behavior Disorder, Parkinson's Disease Dementia
- Interventions
- Nelotanserin, Placebo
- First posted
- 2016-03-15
- Last updated
- 2020-05-20
- Results first posted
- 2020-05-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | 28 days | The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | 28 days | Number of RBD per 10 min | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | Nelotanserin | -1.47 | Standard Error 1.006 | Number of RBD per 10 min | |
| Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | Placebo | -0.26 | Standard Error 1.027 | Number of RBD per 10 min |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nelotanserin | 16 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Nelotanserin | 14 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Nelotanserin | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events50
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 | Anxiety | Psychiatric disorders | Nelotanserin | 1 | 16 | |
| other | Anxiety | Psychiatric disorders | Placebo | 0 | 18 | |
| other | Disorientation | Psychiatric disorders | Nelotanserin | 1 | 16 | 1 |
| other | Disorientation | Psychiatric disorders | Placebo | 0 | 18 | 0 |
| other | Insomnia | Psychiatric disorders | Nelotanserin | 1 | 16 | 1 |
| other | Insomnia | Psychiatric disorders | Placebo | 1 | 18 | 1 |
| other | Paranoia | Psychiatric disorders | Nelotanserin | 1 | 16 | 1 |
| other | Paranoia | Psychiatric disorders | Placebo | 0 | 18 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Nelotanserin | 1 | 16 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 0 | 18 | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nelotanserin | 0 | 16 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, other adverse events | Nelotanserin | 11 | 16 |
| Total, other adverse events | Placebo | 8 | 18 |
| Total, serious adverse events | Nelotanserin | 2 | 16 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33714847 | DERIVED |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nelotanserin vs Placebo: deaths from any cause | Trial comparisons |
| Nelotanserin vs Placebo: serious adverse events | Trial comparisons |
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/NCT02708186
GET https://conductscience.org/api/trials/v1/NCT02708186/events?page=2