Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
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ClinicalTrials.gov Identifier: NCT02708186 |
Recruitment Status :
Completed
First Posted : March 15, 2016
Last Update Posted : October 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dementia With Lewy Bodies REM Sleep Behavior Disorder Parkinson's Disease Dementia | Drug: Nelotanserin Drug: Placebo | Phase 2 |
This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD.
Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD) |
Actual Study Start Date : | March 2016 |
Actual Primary Completion Date : | May 2018 |
Actual Study Completion Date : | May 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Nelotanserin
Nelotanserin 80 mg
|
Drug: Nelotanserin
once daily, oral, 20-mg tablets |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
once daily, oral, matching tablets |
- Change in the frequency of REM sleep behaviors from baseline to the end of the treatment period (28 days) based on a clinical evaluator. [ Time Frame: 28 days ]
- Change in the proportion of severe REM sleep behaviors from baseline to the end of the treatment period (28 days) based on a clinical evaluator. [ Time Frame: 28 days ]
- Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III) [ Time Frame: 28 days ]
- Safety will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and routine clinical laboratory assessments from baseline to the end of the treatment period (28 days). [ Time Frame: 28 days ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnostic criteria
- Presence of frequent REM sleep behavior episodes
- Mini Mental State Examination score ≥ 18
Exclusion Criteria:
- Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
- Subjects' RBD symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708186

Study Director: | Ilise Lombardo, MD | Axovant Sciences, Inc., Clinical Research |
Responsible Party: | Axovant Sciences Ltd. |
ClinicalTrials.gov Identifier: | NCT02708186 History of Changes |
Other Study ID Numbers: |
RVT-102-2002 |
First Posted: | March 15, 2016 Key Record Dates |
Last Update Posted: | October 23, 2018 |
Last Verified: | April 2018 |
Dementia with Lewy bodies Lewy bodies REM sleep behavior disorder Parkinson's disease dementia |
Parkinson Disease Dementia Alzheimer Disease Lewy Body Disease REM Sleep Behavior Disorder Disease Mental Disorders Pathologic Processes Parkinsonian Disorders Basal Ganglia Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Neurocognitive Disorders Tauopathies REM Sleep Parasomnias Parasomnias Sleep Wake Disorders |