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

Phase 2

Completed

• Conditions: Parkinson's Disease Dementia; Dementia With Lewy Bodies; REM Sleep Behavior Disorder
• Interventions: Drug: Nelotanserin; Drug: Placebo

• Registration Number: NCT02708186
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-15
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2020-04
• Results First Submitted: 2020-04-14
• Results First Submitted QC: 2020-05-09
• Last Update Submitted: 2020-05-09
• Results First Posted: 2020-05-20
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nelotanserin	Nelotanserin	Nelotanserin 80 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (23)

US131; 🇺🇸 San Antonio, Texas, United States

US122; 🇺🇸 Englewood, Colorado, United States

US104; 🇺🇸 Cleveland, Ohio, United States

US105; 🇺🇸 Columbus, Ohio, United States

US163; 🇺🇸 Atlanta, Georgia, United States

US132; 🇺🇸 Lenexa, Kansas, United States

US147; 🇺🇸 Fargo, North Dakota, United States

US129; 🇺🇸 Lincoln, Nebraska, United States

US145; 🇺🇸 Sun City, Arizona, United States

US128; 🇺🇸 Memphis, Tennessee, United States

US143; 🇺🇸 Little Rock, Arkansas, United States

US164; 🇺🇸 Phoenix, Arizona, United States

US120; 🇺🇸 Birmingham, Alabama, United States

US107; 🇺🇸 Indianapolis, Indiana, United States

US180; 🇺🇸 Maitland, Florida, United States

US154; 🇺🇸 Ocala, Florida, United States

US113; 🇺🇸 Orlando, Florida, United States

US152; 🇺🇸 Ormond Beach, Florida, United States

US153; 🇺🇸 Tampa, Florida, United States

US159; 🇺🇸 New Bern, North Carolina, United States

US111; 🇺🇸 Cincinnati, Ohio, United States

US173; 🇺🇸 Lincoln, Rhode Island, United States

US101; 🇺🇸 Chapel Hill, North Carolina, United States