NCT02871427

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Axovant Sciences Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Nelotanserin	Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Timeline

• Start date: 2016-10-20
• Primary completion: 2019-01-17
• Completion: 2019-01-17
• First posted: 2016-08-18
• Last updated: 2019-03-27

Locations

19 sites across 1 country: United States