Trial Outcomes & Findings for Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD) (NCT NCT02708186)
NCT ID: NCT02708186
Last Updated: 2020-05-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
28 days
Results posted on
2020-05-20
Participant Flow
Participant milestones
| Measure |
Nelotanserin
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
Placebo: once daily, oral, matching tablets
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Baseline characteristics by cohort
| Measure |
Nelotanserin
n=16 Participants
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
n=18 Participants
Placebo
Placebo: once daily, oral, matching tablets
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
72.2 years
STANDARD_DEVIATION 6.40 • n=7 Participants
|
71.3 years
STANDARD_DEVIATION 6.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe 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.
Outcome measures
| Measure |
Nelotanserin
n=16 Participants
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
n=18 Participants
Placebo
Placebo: once daily, oral, matching tablets
|
|---|---|---|
|
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.
|
-1.47 Number of RBD per 10 min
Standard Error 1.006
|
-0.26 Number of RBD per 10 min
Standard Error 1.027
|
Adverse Events
Nelotanserin
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nelotanserin
n=16 participants at risk
Nelotanserin 80 mg
Nelotanserin: once daily, oral, 20-mg tablets
|
Placebo
n=18 participants at risk
Placebo
Placebo: once daily, oral, matching tablets
|
|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Nervous system disorders
Migraine
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Psychiatric disorders
Mental status changes
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
Other adverse events
| Measure |
Nelotanserin
n=16 participants at risk
Nelotanserin 80 mg
Nelotanserin: once daily, oral, 20-mg tablets
|
Placebo
n=18 participants at risk
Placebo
Placebo: once daily, oral, matching tablets
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Psychiatric disorders
Disorientation
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
Psychiatric disorders
Paranoia
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
Nervous system disorders
Akathisia
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Nervous system disorders
Dystonia
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/16 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
2/16 • Number of events 2 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
5.6%
1/18 • Number of events 1 • 11 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
1/16 • Number of events 1 • 11 weeks
|
0.00%
0/18 • 11 weeks
|
Additional Information
Senior Director of Clinical Research
Axovant Sciences GMBH
Phone: 1-833-296-8268
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place