Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

NCT ID: NCT02871427

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-20

Study Completion Date

2019-01-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs. Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lewy Body Dementia Dementia With Lewy Bodies Parkinson's Disease Dementia Visual Hallucinations REM Sleep Behavior Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nelotanserin

Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Group Type EXPERIMENTAL

Nelotanserin

Intervention Type DRUG

Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nelotanserin

Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with LBD who completed a previous nelotanserin VH or RBD study

Exclusion Criteria

* Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Axovant Sciences Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ilise Lombardo, MD

Role: STUDY_DIRECTOR

Axovant Sciences, Inc., Clinical Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

US120

Birmingham, Alabama, United States

Site Status

US143

Little Rock, Arkansas, United States

Site Status

US114

Boca Raton, Florida, United States

Site Status

US180

Maitland, Florida, United States

Site Status

US154

Ocala, Florida, United States

Site Status

US113

Orlando, Florida, United States

Site Status

US152

Ormond Beach, Florida, United States

Site Status

US107

Indianapolis, Indiana, United States

Site Status

US132

Lenexa, Kansas, United States

Site Status

US103

Rochester, Minnesota, United States

Site Status

US129

Lincoln, Nebraska, United States

Site Status

US101

Chapel Hill, North Carolina, United States

Site Status

US147

Fargo, North Dakota, United States

Site Status

US111

Cincinnati, Ohio, United States

Site Status

US104

Cleveland, Ohio, United States

Site Status

US105

Columbus, Ohio, United States

Site Status

US173

Lincoln, Rhode Island, United States

Site Status

US128

Memphis, Tennessee, United States

Site Status

US131

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RVT-102-2003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Memantine for Agitation in Dementia
NCT00371059 COMPLETED PHASE4
Lorazepam Effects on Neuroimaging Measures
NCT04671836 WITHDRAWN EARLY_PHASE1