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

May 9, 2020 updated by: Axovant Sciences Ltd.

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • US120
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • US164
      • Sun City, Arizona, United States, 85351
        • US145
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • US143
    • Colorado
      • Englewood, Colorado, United States, 80113
        • US122
    • Florida
      • Maitland, Florida, United States, 32751
        • US180
      • Ocala, Florida, United States, 34471
        • US154
      • Orlando, Florida, United States, 32806
        • US113
      • Ormond Beach, Florida, United States, 32174
        • US152
      • Tampa, Florida, United States, 33613
        • US153
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • US163
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • US107
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • US132
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • US129
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • US101
      • New Bern, North Carolina, United States, 28562
        • US159
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • US147
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • US111
      • Cleveland, Ohio, United States, 44195
        • US104
      • Columbus, Ohio, United States, 43210
        • US105
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • US173
    • Tennessee
      • Memphis, Tennessee, United States, 38613
        • US128
    • Texas
      • San Antonio, Texas, United States, 78229
        • US131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
once daily, oral, matching tablets
Experimental: Nelotanserin
Nelotanserin 80 mg
Drug: Nelotanserin
once daily, oral, 20-mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axovant Sciences Ltd.

Investigators

  • Study Director: Ilise Lombardo, MD, Axovant Sciences, Inc., Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVT-102-2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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