CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Nelotanserin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02708186
NCT02708186Phase 2Completed

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)

Axovant Sciences Ltd.·interventional·Posted Mar 15, 2016·Updated May 20, 2020

In Brief

A Phase 2 clinical trial evaluating Nelotanserin and Placebo for Dementia With Lewy Bodies and 2 related conditions. Completed, enrolled 34 participants across 23 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 15, 2016
Enrollment StartMar 1, 2016
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.3 years ago

Interventions

Nelotanserindrug

once daily, oral, 20-mg tablets

Placebodrug

once daily, oral, matching tablets