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

Axovant Sciences

Status and phase: Terminated; Phase 2

Conditions: Parkinson's Disease Dementia; REM Sleep Behavior Disorder; Visual Hallucinations; Lewy Body Dementia; Dementia With Lewy Bodies

Treatments: Drug: Nelotanserin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02871427

RVT-102-2003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Nelotanserin

Experimental group

Description:

Once Daily, Oral, at 20, 40, 60, or 80 mg dose

Treatment:

Drug: Nelotanserin