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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.

Sponsor: Axovant Sciences Ltd.

Current Primary Outcome: Change in the frequency of REM sleep behaviors from baseline to the end of the treatment period (28 days) based on a clinical evaluator. [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in the proportion of severe REM sleep behaviors from baseline to the end of the treatment period (28 days) based on a clinical evaluator. [ Time Frame: 28 days ]

Original Secondary Outcome: Same as current

Information By: Axovant Sciences Ltd.

Dates:
Date Received: March 10, 2016
Date Started: March 2016
Date Completion: June 2017
Last Updated: March 3, 2017
Last Verified: March 2017