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

NCT02708186 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-05-20

Study results available
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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).

Conditions

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

Interventions

DRUG

Nelotanserin

once daily, oral, 20-mg tablets

DRUG

Placebo

once daily, oral, matching tablets

Sponsors & Collaborators

  • Axovant Sciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Ilise Lombardo, MD · Axovant Sciences, Inc., Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02708186 on ClinicalTrials.gov