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

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ClinicalTrials.gov Identifier: NCT02708186
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sio Gene Therapies ( Axovant Sciences Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dementia With Lewy Bodies
REM Sleep Behavior Disorder
Parkinson's Disease Dementia
Interventions Drug: Nelotanserin
Drug: Placebo
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nelotanserin Placebo
Hide Arm/Group Description

Nelotanserin 80 mg

Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin.

Placebo

Placebo: once daily, oral, matching tablets

Period Title: Overall Study
Started 16 18
Completed 14 16
Not Completed 2 2
Arm/Group Title Nelotanserin Placebo Total
Hide Arm/Group Description

Nelotanserin 80 mg

Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin.

Placebo

Placebo: once daily, oral, matching tablets

Total of all reporting groups
Overall Number of Baseline Participants 16 18 34
Hide Baseline Analysis Population Description
The Safety population included subjects who took at least 1 dose of double-blind study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 18 participants 34 participants
70.3  (6.37) 72.2  (6.40) 71.3  (6.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Female
0
   0.0%
5
  27.8%
5
  14.7%
Male
16
 100.0%
13
  72.2%
29
  85.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.3%
0
   0.0%
1
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
15
  93.8%
18
 100.0%
33
  97.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 18 participants 34 participants
16 18 34
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nelotanserin Placebo
Hide Arm/Group Description:

Nelotanserin 80 mg

Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin.

Placebo

Placebo: once daily, oral, matching tablets

Overall Number of Participants Analyzed 16 18
Least Squares Mean (Standard Error)
Unit of Measure: Number of RBD per 10 min
-1.47  (1.006) -0.26  (1.027)
Time Frame 11 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nelotanserin Placebo
Hide Arm/Group Description

Nelotanserin 80 mg

Nelotanserin: once daily, oral, 20-mg tablets

Placebo

Placebo: once daily, oral, matching tablets

All-Cause Mortality
Nelotanserin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
Nelotanserin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      0/18 (0.00%)    
Infections and infestations     
Gastroenteritis viral  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Nervous system disorders     
Migraine  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Psychiatric disorders     
Mental status changes  1  1/16 (6.25%)  1 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nelotanserin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/16 (68.75%)      8/18 (44.44%)    
Gastrointestinal disorders     
Abdominal Pain  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Aphthous ulcer  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Diarrhoea  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Nausea  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Toothache  1  0/16 (0.00%)  0 1/18 (5.56%)  1
General disorders     
Oedema peripheral  1  1/16 (6.25%)  1 1/18 (5.56%)  1
Infections and infestations     
Gastroenteritis viral  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  2/16 (12.50%)  2 0/18 (0.00%)  0
Arthralgia  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Muscle spasms  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Back pain  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Pain in extremity  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders     
Akathisia  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Dystonia  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Tremor  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Dizziness  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Dysarthria  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Syncope  1  0/16 (0.00%)  0 1/18 (5.56%)  1
Psychiatric disorders     
Anxiety  1  1/16 (6.25%)  0/18 (0.00%) 
Disorientation  1  1/16 (6.25%)  1 0/18 (0.00%)  0
Insomnia  1  1/16 (6.25%)  1 1/18 (5.56%)  1
Paranoia  1  1/16 (6.25%)  1 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director of Clinical Research
Organization: Axovant Sciences GMBH
Phone: 1-833-296-8268
EMail: clinicaltrials@axovant.com
Layout table for additonal information
Responsible Party: Sio Gene Therapies ( Axovant Sciences Ltd. )
ClinicalTrials.gov Identifier: NCT02708186    
Other Study ID Numbers: RVT-102-2002
First Submitted: March 10, 2016
First Posted: March 15, 2016
Results First Submitted: April 14, 2020
Results First Posted: May 20, 2020
Last Update Posted: May 20, 2020