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

Phase 2TerminatedNCT02871427

Axovant Sciences Ltd.80 enrolled

Overview

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).

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

NelotanserinDRUG

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (19)

US120

Birmingham, Alabama, United States

US143

Little Rock, Arkansas, United States

US114

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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