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

Dementia With Lewy Bodies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02871427
• Other study ID #: RVT-102-2003
• Status: Terminated
• Phase: Phase 2
• Start date: October 20, 2016
• Est. completion date: January 17, 2019

Study information

• Verified date: March 2019
• Source: Axovant Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Subjects with LBD who completed a previous nelotanserin VH or RBD study

Exclusion Criteria:

• Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia With Lewy Bodies
• Disease
• Hallucinations
• Lewy Body Dementia
• Lewy Body Disease
• Mental Disorders
• Parkinson Disease
• Parkinson's Disease Dementia
• REM Sleep Behavior Disorder
• Visual Hallucinations

Intervention

Drug:
• Nelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Locations

Country	Name	City	State
United States	US120	Birmingham	Alabama
United States	US114	Boca Raton	Florida
United States	US101	Chapel Hill	North Carolina
United States	US111	Cincinnati	Ohio
United States	US104	Cleveland	Ohio
United States	US105	Columbus	Ohio
United States	US147	Fargo	North Dakota
United States	US107	Indianapolis	Indiana
United States	US132	Lenexa	Kansas
United States	US129	Lincoln	Nebraska
United States	US173	Lincoln	Rhode Island
United States	US143	Little Rock	Arkansas
United States	US180	Maitland	Florida
United States	US128	Memphis	Tennessee
United States	US154	Ocala	Florida
United States	US113	Orlando	Florida
United States	US152	Ormond Beach	Florida
United States	US103	Rochester	Minnesota
United States	US131	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Axovant Sciences Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 weeks
Primary	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.		24 weeks