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Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

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ClinicalTrials.gov Identifier: NCT02871427
Recruitment Status : Terminated (Changes to the overall development program for the study medication)
First Posted : August 18, 2016
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.

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).

Condition or disease Intervention/treatment Phase
Lewy Body Dementia Dementia With Lewy Bodies Parkinson's Disease Dementia Visual Hallucinations REM Sleep Behavior Disorder Drug: Nelotanserin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder
Actual Study Start Date : October 20, 2016
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : January 17, 2019


Arm Intervention/treatment
Experimental: Nelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose
Drug: Nelotanserin
Once Daily, Oral, at 20, 40, 60, or 80 mg dose




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871427


Locations
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United States, Alabama
US120
Birmingham, Alabama, United States, 35294
United States, Arkansas
US143
Little Rock, Arkansas, United States, 77205
United States, Florida
US114
Boca Raton, Florida, United States, 33486
US180
Maitland, Florida, United States, 32751
US154
Ocala, Florida, United States, 34471
US113
Orlando, Florida, United States, 32806
US152
Ormond Beach, Florida, United States, 32174
United States, Indiana
US107
Indianapolis, Indiana, United States, 46202
United States, Kansas
US132
Lenexa, Kansas, United States, 66214
United States, Minnesota
US103
Rochester, Minnesota, United States, 55905
United States, Nebraska
US129
Lincoln, Nebraska, United States, 68526
United States, North Carolina
US101
Chapel Hill, North Carolina, United States, 27514
United States, North Dakota
US147
Fargo, North Dakota, United States, 58103
United States, Ohio
US111
Cincinnati, Ohio, United States, 45229
US104
Cleveland, Ohio, United States, 44195
US105
Columbus, Ohio, United States, 43210
United States, Rhode Island
US173
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
US128
Memphis, Tennessee, United States, 38163
United States, Texas
US131
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
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Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Clinical Research

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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02871427     History of Changes
Other Study ID Numbers: RVT-102-2003
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Keywords provided by Axovant Sciences Ltd.:
Lewy body dementia
Dementia with Lewy bodies
Parkinson's disease dementia
Visual hallucinations
REM sleep behavior disorder
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Parkinson Disease
Alzheimer Disease
Hallucinations
REM Sleep Behavior Disorder
Disease
Mental Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Tauopathies
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders