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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 : Active, not recruiting
First Posted : March 15, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.

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 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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Other Outcome Measures:
  1. 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
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


  Show 23 Study Locations
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Clinical Research

Additional Information:
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: April 11, 2018
Last Verified: April 2018

Keywords provided by Axovant Sciences Ltd.:
Dementia with Lewy bodies
Lewy bodies
REM sleep behavior disorder
Parkinson's disease dementia

Additional relevant MeSH terms:
Disease
Parkinson Disease
Dementia
Alzheimer Disease
Mental Disorders
Lewy Body Disease
REM Sleep Behavior Disorder
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