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

Phase 2

Terminated

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

• Registration Number: NCT02871427
• Lead Sponsor: Axovant Sciences Ltd.

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).

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 Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Study Start: 2016-10-20
• Primary Completion: 2019-01-17
• Study Completion: 2019-01-17
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nelotanserin	Nelotanserin	Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

US143; 🇺🇸 Little Rock, Arkansas, United States

US129; 🇺🇸 Lincoln, Nebraska, United States

US104; 🇺🇸 Cleveland, Ohio, United States

US114; 🇺🇸 Boca Raton, Florida, United States

US180; 🇺🇸 Maitland, Florida, United States

US113; 🇺🇸 Orlando, Florida, United States

US154; 🇺🇸 Ocala, Florida, United States

US152; 🇺🇸 Ormond Beach, Florida, United States

US132; 🇺🇸 Lenexa, Kansas, United States

US103; 🇺🇸 Rochester, Minnesota, United States

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

US105; 🇺🇸 Columbus, Ohio, United States

US120; 🇺🇸 Birmingham, Alabama, United States

US107; 🇺🇸 Indianapolis, Indiana, United States

US131; 🇺🇸 San Antonio, Texas, United States

US111; 🇺🇸 Cincinnati, Ohio, United States

US147; 🇺🇸 Fargo, North Dakota, United States

US128; 🇺🇸 Memphis, Tennessee, United States

US173; 🇺🇸 Lincoln, Rhode Island, United States