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

A

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)

80 participants in 1 patient group

Nelotanserin
Experimental group
Description:
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
Treatment:
Drug: Nelotanserin

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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