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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02708186
Other study ID # RVT-102-2002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date May 2018

Study information

Verified date April 2020
Source Axovant Sciences Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Nelotanserin
once daily, oral, 20-mg tablets
Placebo
once daily, oral, matching tablets

Locations

Country Name City State
United States US163 Atlanta Georgia
United States US120 Birmingham Alabama
United States US101 Chapel Hill North Carolina
United States US111 Cincinnati Ohio
United States US104 Cleveland Ohio
United States US105 Columbus Ohio
United States US122 Englewood Colorado
United States US147 Fargo North Dakota
United States US107 Indianapolis Indiana
United States US132 Lenexa Kansas
United States US129 Lincoln Nebraska
United States US173 Lincoln Rhode Island
United States US143 Little Rock Arkansas
United States US180 Maitland Florida
United States US128 Memphis Tennessee
United States US159 New Bern North Carolina
United States US154 Ocala Florida
United States US113 Orlando Florida
United States US152 Ormond Beach Florida
United States US164 Phoenix Arizona
United States US131 San Antonio Texas
United States US145 Sun City Arizona
United States US153 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Axovant Sciences Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents. 28 days
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