Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
NCT ID: NCT02708186
Last Updated: 2020-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2016-03-31
2018-05-31
Brief Summary
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Detailed Description
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Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nelotanserin
Nelotanserin 80 mg
Nelotanserin
once daily, oral, 20-mg tablets
Placebo
Placebo
Placebo
once daily, oral, matching tablets
Interventions
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Nelotanserin
once daily, oral, 20-mg tablets
Placebo
once daily, oral, matching tablets
Eligibility Criteria
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Inclusion Criteria
* Presence of frequent REM sleep behavior episodes
* Mini Mental State Examination score ≥ 18
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Axovant Sciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ilise Lombardo, MD
Role: STUDY_DIRECTOR
Axovant Sciences, Inc., Clinical Research
Locations
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US120
Birmingham, Alabama, United States
US164
Phoenix, Arizona, United States
US145
Sun City, Arizona, United States
US143
Little Rock, Arkansas, United States
US122
Englewood, Colorado, United States
US180
Maitland, Florida, United States
US154
Ocala, Florida, United States
US113
Orlando, Florida, United States
US152
Ormond Beach, Florida, United States
US153
Tampa, Florida, United States
US163
Atlanta, Georgia, United States
US107
Indianapolis, Indiana, United States
US132
Lenexa, Kansas, United States
US129
Lincoln, Nebraska, United States
US101
Chapel Hill, North Carolina, United States
US159
New Bern, North Carolina, United States
US147
Fargo, North Dakota, United States
US111
Cincinnati, Ohio, United States
US104
Cleveland, Ohio, United States
US105
Columbus, Ohio, United States
US173
Lincoln, Rhode Island, United States
US128
Memphis, Tennessee, United States
US131
San Antonio, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RVT-102-2002
Identifier Type: -
Identifier Source: org_study_id
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