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

• ClinicalTrials.gov Identifier: NCT02871427
• Recruitment Status: Terminated
• First Posted: August 18, 2016
• Last Update Posted: March 27, 2019
• Sponsor: Axovant Sciences Ltd.
• Information provided by (Responsible Party): Axovant Sciences Ltd.

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Lewy Body Dementia; Dementia With Lewy Bodies; Parkinson's Disease Dementia; Visual Hallucinations; REM Sleep Behavior Disorder	Drug: Nelotanserin	Phase 2

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
• Actual Study Start Date: October 20, 2016
• Actual Primary Completion Date: January 17, 2019
• Actual Study Completion Date: January 17, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nelotanserin; Once Daily, Oral, at 20, 40, 60, or 80 mg dose	Drug: Nelotanserin; Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Outcome Measures

Primary Outcome Measures :

1. Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment. [ Time Frame: 24 weeks ]
2. Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment. [ Time Frame: 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

US120

Birmingham, Alabama, United States, 35294

United States, Arkansas

US143

Little Rock, Arkansas, United States, 77205

United States, Florida

US114

Boca Raton, Florida, United States, 33486

US180

Maitland, Florida, United States, 32751

US154

Ocala, Florida, United States, 34471

US113

Orlando, Florida, United States, 32806

US152

Ormond Beach, Florida, United States, 32174

United States, Indiana

US107

Indianapolis, Indiana, United States, 46202

United States, Kansas

US132

Lenexa, Kansas, United States, 66214

United States, Minnesota

US103

Rochester, Minnesota, United States, 55905

United States, Nebraska

US129

Lincoln, Nebraska, United States, 68526

United States, North Carolina

US101

Chapel Hill, North Carolina, United States, 27514

United States, North Dakota

US147

Fargo, North Dakota, United States, 58103

United States, Ohio

US111

Cincinnati, Ohio, United States, 45229

US104

Cleveland, Ohio, United States, 44195

US105

Columbus, Ohio, United States, 43210

United States, Rhode Island

US173

Lincoln, Rhode Island, United States, 02865

United States, Tennessee

US128

Memphis, Tennessee, United States, 38163

United States, Texas

US131

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Axovant Sciences Ltd.

Investigators

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

More Information

• Responsible Party: Axovant Sciences Ltd.
• ClinicalTrials.gov Identifier: NCT02871427 History of Changes
• Other Study ID Numbers: RVT-102-2003
• First Posted: August 18, 2016
• Last Update Posted: March 27, 2019
• Last Verified: March 2019

Keywords provided by Axovant Sciences Ltd.:

Lewy body dementia; Dementia with Lewy bodies; Parkinson's disease dementia; Visual hallucinations; REM sleep behavior disorder

Additional relevant MeSH terms:

Parkinson Disease; Dementia; Hallucinations; Lewy Body Disease; Alzheimer Disease; REM Sleep Behavior Disorder; Disease; Mental Disorders; Pathologic Processes; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Neurocognitive Disorders; Tauopathies; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders