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 |
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Recruitment Status :
Completed
First Posted : March 15, 2016
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
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Sponsor:
Axovant Sciences Ltd.
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )
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Brief Summary:
This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dementia With Lewy Bodies REM Sleep Behavior Disorder Parkinson's Disease Dementia | Drug: Nelotanserin Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nelotanserin
Nelotanserin 80 mg
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Drug: Nelotanserin
once daily, oral, 20-mg tablets |
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo
once daily, oral, matching tablets |
Primary Outcome Measures :
- 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. [ Time Frame: 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Locations
Show 23 study locations
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
| Study Director: | Ilise Lombardo, MD | Axovant Sciences, Inc., Clinical Research |
Study Documents (Full-Text)
Documents provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Documents provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Study Protocol and Statistical Analysis Plan [PDF] July 5, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Axovant Sciences Ltd. |
| ClinicalTrials.gov Identifier: | NCT02708186 |
| Other Study ID Numbers: |
RVT-102-2002 |
| First Posted: | March 15, 2016 Key Record Dates |
| Results First Posted: | May 20, 2020 |
| Last Update Posted: | May 20, 2020 |
| Last Verified: | April 2020 |
Keywords provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
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Dementia with Lewy bodies Lewy bodies REM sleep behavior disorder Parkinson's disease dementia |
Additional relevant MeSH terms:
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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 |