Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
NCT02871427 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2019-03-27
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).
Conditions
- Lewy Body Dementia
- Dementia With Lewy Bodies
- Parkinson's Disease Dementia
- Visual Hallucinations
- REM Sleep Behavior Disorder
Interventions
- DRUG
-
Nelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
Sponsors & Collaborators
-
Axovant Sciences Ltd.
lead INDUSTRY
Principal Investigators
-
Ilise Lombardo, MD · Axovant Sciences, Inc., Clinical Research
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-20
- Primary Completion
- 2019-01-17
- Completion
- 2019-01-17
Countries
- United States
Study Locations
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