Study Stopped
Changes to the overall development program for the study medication
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
1 other identifier
interventional
80
1 country
19
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2016
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedStudy Start
First participant enrolled
October 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2019
CompletedMarch 27, 2019
March 1, 2019
2.2 years
August 15, 2016
March 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Nelotanserin
EXPERIMENTALOnce Daily, Oral, at 20, 40, 60, or 80 mg dose
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with LBD who completed a previous nelotanserin VH or RBD study
You may not qualify if:
- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
US120
Birmingham, Alabama, 35294, United States
US143
Little Rock, Arkansas, 77205, United States
US114
Boca Raton, Florida, 33486, United States
US180
Maitland, Florida, 32751, United States
US154
Ocala, Florida, 34471, United States
US113
Orlando, Florida, 32806, United States
US152
Ormond Beach, Florida, 32174, United States
US107
Indianapolis, Indiana, 46202, United States
US132
Lenexa, Kansas, 66214, United States
US103
Rochester, Minnesota, 55905, United States
US129
Lincoln, Nebraska, 68526, United States
US101
Chapel Hill, North Carolina, 27514, United States
US147
Fargo, North Dakota, 58103, United States
US111
Cincinnati, Ohio, 45229, United States
US104
Cleveland, Ohio, 44195, United States
US105
Columbus, Ohio, 43210, United States
US173
Lincoln, Rhode Island, 02865, United States
US128
Memphis, Tennessee, 38163, United States
US131
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ilise Lombardo, MD
Axovant Sciences, Inc., Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2016
First Posted
August 18, 2016
Study Start
October 20, 2016
Primary Completion
January 17, 2019
Study Completion
January 17, 2019
Last Updated
March 27, 2019
Record last verified: 2019-03