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Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02708186
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )

Study Description
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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

Detailed Description:

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 Design
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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


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Contacts and Locations
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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
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Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
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Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Clinical Research
  Study Documents (Full-Text)

Documents provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Study Protocol and Statistical Analysis Plan  [PDF] July 5, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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. ):
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
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Tauopathies
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders