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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02871427
First Posted: August 18, 2016
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Axovant Sciences Ltd.
  Purpose
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 Intervention Phase
Lewy Body Dementia Dementia With Lewy Bodies Parkinson's Disease Dementia Visual Hallucinations REM Sleep Behavior Disorder Drug: Nelotanserin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Axovant Sciences Ltd.:

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. [ Time Frame: 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. [ Time Frame: 24 weeks ]

Estimated Enrollment: 80
Study Start Date: August 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
United States, California
US123
Fountain Valley, California, United States, 92708
United States, Florida
US114
Boca Raton, Florida, United States, 33486
US154
Ocala, Florida, United States, 34471
US113
Orlando, Florida, United States, 32806
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, Ohio
US104
Cleveland, Ohio, United States, 44195
US105
Columbus, Ohio, United States, 43210
United States, Texas
US131
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
Study Director: Warren Wen Axovant Sciences, Inc., Clinical Research
  More Information

Additional Information:
Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02871427     History of Changes
Other Study ID Numbers: RVT-102-2003
First Submitted: August 15, 2016
First Posted: August 18, 2016
Last Update Posted: July 2, 2017
Last Verified: June 2017

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:
Disease
Parkinson Disease
Dementia
Alzheimer Disease
Mental Disorders
Hallucinations
Lewy Body Disease
REM Sleep Behavior Disorder
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