Clinical Trial: Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder

Brief 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 Summary: 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.
Sponsor: Axovant Sciences Ltd.

Current Primary Outcome:

  • Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment. [ Time Frame: 24 weeks ]
  • Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment. [ Time Frame: 24 weeks ]


Original Primary Outcome:

  • Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment. [ Time Frame: 24 weeks ]
  • Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations and/or REM sleep behaviors over time during treatment. [ Time Frame: 24 weeks ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Axovant Sciences Ltd.

Dates:
Date Received: August 15, 2016
Date Started: August 2016
Date Completion: July 2018
Last Updated: February 9, 2017
Last Verified: February 2017