NCT02708186

Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Axovant Sciences Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

Detailed description

This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD. Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.

Conditions

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

Interventions

Type	Name	Description
DRUG	Nelotanserin	once daily, oral, 20-mg tablets
DRUG	Placebo	once daily, oral, matching tablets

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2016-03-15
• Last updated: 2020-05-20
• Results posted: 2020-05-20

Locations

23 sites across 1 country: United States