Back to resultsOpen-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
Primary Purpose
Lewy Body Dementia, Dementia With Lewy Bodies, Parkinson's Disease Dementia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nelotanserin
Sponsored by
About this trial
This is an interventional treatment trial for Lewy Body Dementia focused on measuring Lewy body dementia, Dementia with Lewy bodies, Parkinson's disease dementia, Visual hallucinations, REM sleep behavior disorder
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
Sites / Locations
- US120
- US143
- US114
- US180
- US154
- US113
- US152
- US107
- US132
- US103
- US129
- US101
- US147
- US111
- US104
- US105
- US173
- US128
- US131
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nelotanserin
Arm Description
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02871427
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Changes to the overall development program for the study medication
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axovant Sciences Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nelotanserin
Arm Type
Experimental
Arm Description
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
Intervention Type
Drug
Intervention Name(s)
Nelotanserin
Intervention Description
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
Primary Outcome Measure Information:
Title
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.
Time Frame
24 weeks
Title
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilise Lombardo, MD
Organizational Affiliation
Axovant Sciences, Inc., Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
US120
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
US143
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
77205
Country
United States
Facility Name
US114
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
US180
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
US154
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
US113
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
US152
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
US107
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
US132
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
US103
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
US129
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
US101
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
US147
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
US111
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
US104
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
US105
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
US173
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
US128
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
US131
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
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