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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).
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.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
US120
Birmingham, Alabama, United States
US143
Little Rock, Arkansas, United States
US114
Boca Raton, Florida, United States
US180
Maitland, Florida, United States
US154
Ocala, Florida, United States
US113
Orlando, Florida, United States
US152
Ormond Beach, Florida, United States
US107
Indianapolis, Indiana, United States
US132
Lenexa, Kansas, United States
US103
Rochester, Minnesota, United States
Start Date
October 20, 2016
Primary Completion Date
January 17, 2019
Completion Date
January 17, 2019
Last Updated
March 27, 2019
80
ESTIMATED participants
Nelotanserin
DRUG
Lead Sponsor
Axovant Sciences Ltd.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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