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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 : 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. )

Tracking Information
First Submitted Date  ICMJE March 10, 2016
First Posted Date  ICMJE March 15, 2016
Results First Submitted Date  ICMJE April 14, 2020
Results First Posted Date  ICMJE May 20, 2020
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
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 History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 14, 2016)
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 ]
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Official Title  ICMJE 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)
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dementia With Lewy Bodies
  • REM Sleep Behavior Disorder
  • Parkinson's Disease Dementia
Intervention  ICMJE
  • Drug: Nelotanserin
    once daily, oral, 20-mg tablets
  • Drug: Placebo
    once daily, oral, matching tablets
Study Arms  ICMJE
  • Experimental: Nelotanserin
    Nelotanserin 80 mg
    Intervention: Drug: Nelotanserin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Stefani A, Santamaria J, Iranzo A, Hackner H, Schenck CH, Högl B. Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson's disease dementia. Sleep Med. 2021 Feb 25;81:180-187. doi: 10.1016/j.sleep.2021.02.038. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2020)
34
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
60
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02708186
Other Study ID Numbers  ICMJE RVT-102-2002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sio Gene Therapies ( Axovant Sciences Ltd. )
Study Sponsor  ICMJE Axovant Sciences Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Clinical Research
PRS Account Sio Gene Therapies
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP