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

Key information

Conditions

Dementia With Lewy Bodies Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parasomnias Parkinson's Disease Dementia Parkinsonian Disorders REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

US120, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nelotanserin

Drug

once daily, oral, 20-mg tablets

Placebo

Drug

once daily, oral, matching tablets

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Axovant Sciences Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Mar 15, 2016
Registry last updated: May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed