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

An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder

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).

Study Overview

• Status: Terminated
• Conditions: REM Sleep Behavior Disorder; Dementia With Lewy Bodies; Lewy Body Dementia; Parkinson's Disease Dementia; Visual Hallucinations
• Intervention / Treatment: Drug: Nelotanserin

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • US120
  • Arkansas
    • Little Rock, Arkansas, United States, 77205
      • US143
  • Florida
    • Boca Raton, Florida, United States, 33486
      • US114
    • 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
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • US107
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • US132
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • US103
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • US129
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • US101
  • 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, 38163
      • US128
  • Texas
    • San Antonio, Texas, United States, 78229
      • US131

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	24 weeks
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.	24 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Click on Nelotanserin for more information

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: REM sleep behavior disorder; Lewy body dementia; Dementia with Lewy bodies; Parkinson's disease dementia; Visual hallucinations
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parasomnias; Tauopathies; Perceptual Disorders; REM Sleep Parasomnias; Disease; Parkinson Disease; Mental Disorders; Dementia; Alzheimer Disease; Lewy Body Disease; Hallucinations; REM Sleep Behavior Disorder
• Other Study ID Numbers: RVT-102-2003