Clinical trial NCT02871427: Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
Official title: An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lewy Body Dementia
Dementia With Lewy Bodies
Parkinson's Disease Dementia
Visual Hallucinations
REM Sleep Behavior Disorder
Keywords: Lewy body dementia
Dementia with Lewy bodies
Parkinson's disease dementia
Visual hallucinations
REM sleep behavior disorder
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: US120
state: Alabama
city: Little Rock
country: United States
facility: US143
state: Arkansas
city: Boca Raton
country: United States
facility: US114
state: Florida
city: Maitland
country: United States
facility: US180
state: Florida
city: Ocala
country: United States
facility: US154
state: Florida
city: Orlando
country: United States
facility: US113
state: Florida
city: Ormond Beach
country: United States
facility: US152
state: Florida
city: Indianapolis
country: United States
facility: US107
state: Indiana
city: Lenexa
country: United States
facility: US132
state: Kansas
city: Rochester
country: United States
facility: US103
state: Minnesota
city: Lincoln
country: United States
facility: US129
state: Nebraska
city: Chapel Hill
country: United States
facility: US101
state: North Carolina
city: Fargo
country: United States
facility: US147
state: North Dakota
city: Cincinnati
country: United States
facility: US111
state: Ohio
city: Cleveland
country: United States
facility: US104
state: Ohio
city: Columbus
country: United States
facility: US105
state: Ohio
city: Lincoln
country: United States
facility: US173
state: Rhode Island
city: Memphis
country: United States
facility: US128
state: Tennessee
city: San Antonio
country: United States
facility: US131
state: Texas
Study officials:
affiliation: Axovant Sciences, Inc., Clinical Research
name: Ilise Lombardo, MD
role: STUDY_DIRECTOR
References: