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Study Evaluating Nelotanserin for Treatment of Visual Hallucinations in Subjects With Lewy Body Dementia

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.
ClinicalTrials.gov Identifier: NCT02640729
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )

Brief Summary:
This study seeks to evaluate safety and efficacy of Nelotanserin for the treatment of visual hallucinations in subjects with Lewy body dementia.

Condition or disease Intervention/treatment Phase
Lewy Body Dementia Visual Hallucinations Drug: Nelotanserin Drug: Placebo Phase 2

Detailed Description:

This is a double-blind, randomized, placebo-controlled, cross-over study in subjects with Lewy body dementia who experience frequent visual hallucinations.

Subjects who meet the randomization criteria enter the double-blind treatment period.

Each subject will be randomized 1:1 to one of the 2 treatment sequences: Nelotanserin in the first treatment period followed by placebo in the second treatment period, or placebo in the first treatment period followed by Nelotanserin in the second treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Randomized, Placebo-controlled Cross-over Study of Nelotanserin Versus Placebo in Lewy Body Dementia (LBD) Subjects Experiencing Visual Hallucinations (VH)
Actual Study Start Date : December 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: Nelotanserin
Nelotanserin 40mg then nelotanserin 80 mg
Drug: Nelotanserin
once daily, oral, 20-mg tablets

Placebo Comparator: Placebo
Drug: Placebo
once daily, oral, matching tablets

Primary Outcome Measures :
  1. Safety will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and routine clinical laboratory assessments from baseline to the end of each treatment period (28 days). [ Time Frame: 28 days ]
  2. Extrapyramidal signs are assessed with the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS, Parts II and III). [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Change in the frequency and severity of visual hallucinations from baseline to the end of each treatment period (28 days) with Nelotanserin or placebo, as recorded and documented by the patient's caregiver [ Time Frame: 28 days ]

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

Inclusion Criteria:

  • Adult subjects at least 50 years of age, with a diagnosis of LBD based on DSM-5 diagnostic criteria or diagnosis of Parkinson's disease dementia (PDD) based on DSM-5 diagnostic criteria;
  • Presence of frequent visual hallucinations
  • 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' psychotic 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

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): NCT02640729

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United States, California
Fountain Valley, California, United States, 92708
United States, Florida
Boca Raton, Florida, United States, 33486
Orlando, Florida, United States, 32806
United States, Kansas
Lenexa, Kansas, United States, 66214
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Nebraska
Lincoln, Nebraska, United States, 68526
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43210
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Axovant Sciences Ltd.
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Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Clinical Research
Additional Information:
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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02640729    
Other Study ID Numbers: RVT-102-2001
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Keywords provided by Sio Gene Therapies ( Axovant Sciences Ltd. ):
Lewy body dementia
Dementia with Lewy bodies
Parkinson's disease dementia
Lewy bodies
Visual hallucinations
Additional relevant MeSH terms:
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Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders