Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Primary Purpose
Dementia With Lewy Bodies, REM Sleep Behavior Disorder, Parkinson's Disease Dementia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nelotanserin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dementia With Lewy Bodies focused on measuring Dementia with Lewy bodies, Lewy bodies, REM sleep behavior disorder, Parkinson's disease dementia
Eligibility Criteria
Inclusion Criteria:
- Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnostic criteria
- Presence of frequent REM sleep behavior episodes
- Mini Mental State Examination score ≥ 18
Exclusion Criteria:
- Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
- Subjects' RBD symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
- Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Sites / Locations
- US120
- US164
- US145
- US143
- US122
- US180
- US154
- US113
- US152
- US153
- US163
- US107
- US132
- US129
- US101
- US159
- US147
- US111
- US104
- US105
- US173
- US128
- US131
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nelotanserin
Placebo
Arm Description
Nelotanserin 80 mg
Placebo
Outcomes
Primary Outcome Measures
Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator.
The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02708186
Brief Title
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Official Title
A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (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 safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).
Detailed Description
This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD.
Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies, REM Sleep Behavior Disorder, Parkinson's Disease Dementia
Keywords
Dementia with Lewy bodies, Lewy bodies, REM sleep behavior disorder, Parkinson's disease dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nelotanserin
Arm Type
Experimental
Arm Description
Nelotanserin 80 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Nelotanserin
Intervention Description
once daily, oral, 20-mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily, oral, matching tablets
Primary Outcome Measure Information:
Title
Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator.
Description
The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnostic criteria
Presence of frequent REM sleep behavior episodes
Mini Mental State Examination score ≥ 18
Exclusion Criteria:
Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
Subjects' RBD symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
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
US164
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
US145
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
US143
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
US122
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
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
US153
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
US163
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
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
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
US159
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
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
38613
Country
United States
Facility Name
US131
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33714847
Citation
Stefani A, Santamaria J, Iranzo A, Hackner H, Schenck CH, Hogl B. Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson's disease dementia. Sleep Med. 2021 May;81:180-187. doi: 10.1016/j.sleep.2021.02.038. Epub 2021 Feb 25.
Results Reference
derived
Learn more about this trial
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
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