This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 2 of 3 for:    nelotanserin

Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Axovant Sciences Ltd.
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT02708186
First received: March 10, 2016
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
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).

Condition Intervention Phase
Dementia With Lewy Bodies REM Sleep Behavior Disorder Parkinson's Disease Dementia Drug: Nelotanserin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Axovant Sciences Ltd.:

Primary Outcome Measures:
  • Change in the frequency of REM sleep behaviors from baseline to the end of the treatment period (28 days) based on a clinical evaluator. [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Change in the proportion of severe REM sleep behaviors from baseline to the end of the treatment period (28 days) based on a clinical evaluator. [ Time Frame: 28 days ]

Other Outcome Measures:
  • 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 the treatment period (28 days). [ Time Frame: 28 days ]

Estimated Enrollment: 60
Study Start Date: March 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nelotanserin
Nelotanserin 80 mg
Drug: Nelotanserin
once daily, oral, 20-mg tablets
Placebo Comparator: Placebo
Placebo
Drug: Placebo
once daily, oral, matching tablets

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02708186

Contacts
Contact: Axovant Clinical Trials; https://www.lbda.org/nelotanserin-RBD 919-425-0709
Contact: Lydia Hatfield

Locations
United States, Alabama
US120 Recruiting
Birmingham, Alabama, United States, 35294
United States, California
US123 Recruiting
Fountain Valley, California, United States, 92708
United States, Colorado
US122 Recruiting
Englewood, Colorado, United States, 80113
United States, Florida
US154 Recruiting
Ocala, Florida, United States, 34471
US113 Recruiting
Orlando, Florida, United States, 32806
US152 Recruiting
Ormond Beach, Florida, United States, 32174
United States, Indiana
US107 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
US132 Recruiting
Lenexa, Kansas, United States, 66214
United States, Michigan
US157 Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Nebraska
US129 Recruiting
Lincoln, Nebraska, United States, 68526
United States, North Carolina
US101 Recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
US111 Recruiting
Cincinnati, Ohio, United States, 45229
US104 Recruiting
Cleveland, Ohio, United States, 44195
US105 Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
US131 Recruiting
San Antonio, Texas, United States, 78229
United States, Wisconsin
US121 Recruiting
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
Study Director: Nicholas France Axovant Sciences, Inc., Clinical Research
  More Information

Additional Information:
Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02708186     History of Changes
Other Study ID Numbers: RVT-102-2002
Study First Received: March 10, 2016
Last Updated: March 3, 2017

Keywords provided by Axovant Sciences Ltd.:
Dementia with Lewy bodies
Lewy bodies
REM sleep behavior disorder
Parkinson's disease dementia

Additional relevant MeSH terms:
Disease
Parkinson Disease
Dementia
Alzheimer Disease
Mental Disorders
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
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders

ClinicalTrials.gov processed this record on June 23, 2017