Trial Outcomes & Findings for A Pilot Study of Suvorexant for Insomnia in Parkinson Disease (NCT NCT02729714)
NCT ID: NCT02729714
Last Updated: 2024-08-20
Results Overview
Sleep efficiency is defined as total sleep time divided by total time in bed, expressed as a percent. Polysomnograms were performed at baseline, end of treatment period 1, and end of treatment period 2. A positive change indicates improvement in sleep efficiency. Assessing difference between change in sleep efficiency during suvorexant period and change in sleep efficiency during placebo period.
COMPLETED
PHASE4
21 participants
4 weeks
2024-08-20
Participant Flow
Participant milestones
| Measure |
Suvorexant Then Placebo
10 Suvorexant or Placebo mg orally at bedtime with an optional up-titration to 15 mg Suvorexant or Placebo orally at bedtime after 2 weeks. The first treatment period will be 4 weeks. In this group, subjects were randomized 1:1 to receive Suvorexant in the first period. Following a 2 week washout period with placebo, subjects in this group were crossed over into the placebo group for the second treatment period, also 4 weeks.
|
Placebo Then Suvorexant
10 Suvorexant or Placebo mg orally at bedtime with an optional up-titration to 15 mg Suvorexant or Placebo orally at bedtime after 2 weeks. The first treatment period will be 4 weeks. In this group, subjects were randomized 1:1 to receive Placebo in the first period. Following a 2 week washout period with placebo, subjects in this group were crossed over into the suvorexant group for the second treatment period, also 4 weeks.
|
|---|---|---|
|
Treatment Period 1 (4 Weeks)
STARTED
|
11
|
10
|
|
Treatment Period 1 (4 Weeks)
COMPLETED
|
11
|
10
|
|
Treatment Period 1 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (2 Weeks)
STARTED
|
11
|
10
|
|
Washout Period (2 Weeks)
COMPLETED
|
11
|
9
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2 (4 Weeks)
STARTED
|
11
|
9
|
|
Treatment Period 2 (4 Weeks)
COMPLETED
|
11
|
8
|
|
Treatment Period 2 (4 Weeks)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of Suvorexant for Insomnia in Parkinson Disease
Baseline characteristics by cohort
| Measure |
Suvorexant Then Placebo
n=11 Participants
10 Suvorexant or Placebo mg orally at bedtime with an optional up-titration to 15 mg Suvorexant or Placebo orally at bedtime after 2 weeks. The first treatment period will be 4 weeks. In this group, subjects were randomized 1:1 to receive Suvorexant in the first period. Following a 2 week washout period with placebo, subjects in this group were crossed over into the placebo group for the second treatment period, also 4 weeks.
|
Placebo Then Suvorexant
n=10 Participants
10 Suvorexant or Placebo mg orally at bedtime with an optional up-titration to 15 mg Suvorexant or Placebo orally at bedtime after 2 weeks. The first treatment period will be 4 weeks. In this group, subjects were randomized 1:1 to receive Placebo in the first period. Following a 2 week washout period with placebo, subjects in this group were crossed over into the suvorexant group for the second treatment period, also 4 weeks.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
55.9 years
STANDARD_DEVIATION 5.6 • n=107 Participants
|
60.2 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Years since diagnosis of Parkinson disease
|
3.4 years
STANDARD_DEVIATION 3.0 • n=99 Participants
|
3.9 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
3.7 years
STANDARD_DEVIATION 2.7 • n=206 Participants
|
|
Levodopa-Equivalent Daily Dose
|
687.8 mg
STANDARD_DEVIATION 336.0 • n=99 Participants
|
676.9 mg
STANDARD_DEVIATION 213.6 • n=107 Participants
|
682.6 mg
STANDARD_DEVIATION 277.5 • n=206 Participants
|
|
Hoehn & Yahr Stage
|
2 Stage
n=99 Participants
|
2 Stage
n=107 Participants
|
2 Stage
n=206 Participants
|
|
MDS-UPDRS Part 3 Score
|
24 units on a scale
n=99 Participants
|
24.5 units on a scale
n=107 Participants
|
24 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksSleep efficiency is defined as total sleep time divided by total time in bed, expressed as a percent. Polysomnograms were performed at baseline, end of treatment period 1, and end of treatment period 2. A positive change indicates improvement in sleep efficiency. Assessing difference between change in sleep efficiency during suvorexant period and change in sleep efficiency during placebo period.
Outcome measures
| Measure |
Suvorexant Period
n=19 Participants
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=19 Participants
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Change in Sleep Efficiency as Measured by Polysomnogram
|
8.9 Percentage (see sleep efficiency def)
Interval -3.1 to 14.5
|
9.4 Percentage (see sleep efficiency def)
Interval 3.2 to 13.6
|
SECONDARY outcome
Timeframe: 4 weeksWakefulness after sleep onset (WASO) is defined as total time spent awake after first epoch of sleep and before final awakening. Captured during polysomnograms performed at baseline, end of treatment period 1, and end of treatment period 2. Measured in minutes. A negative change indicates improvement in WASO.
Outcome measures
| Measure |
Suvorexant Period
n=19 Participants
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=19 Participants
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Wakefulness After Sleep Onset (WASO)
|
-54.1 Minutes
Interval -61.0 to 22.5
|
-36.5 Minutes
Interval -54.0 to 0.0
|
SECONDARY outcome
Timeframe: 4 weeksLatency to Persistent Sleep (LPS) is defined as total time between lights out and first epoch of sleep. Measured on polysomnogram performed at baseline, end of treatment period 1, and end of treatment period 2. A negative change indicates improvement in LPS.
Outcome measures
| Measure |
Suvorexant Period
n=19 Participants
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=19 Participants
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Latency to Persistent Sleep (LPS)
|
-9.4 Minutes
Interval -26.1 to 1.3
|
-4.2 Minutes
Interval -11.2 to 0.0
|
SECONDARY outcome
Timeframe: 4 weeksThe Insomnia Severity Index (ISI) is a 7-question survey assessing symptoms of insomnia. Scores range from 0 to 28, with higher scores indicating greater severity. Thus, a negative change in the ISI score indicates improvement in sleep. Performed at baseline, end of treatment period 1, start of treatment period 2, and end of treatment period 2.
Outcome measures
| Measure |
Suvorexant Period
n=19 Participants
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=19 Participants
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
-1 units on a scale
Interval -4.0 to 0.0
|
1 units on a scale
Interval -0.5 to 3.5
|
SECONDARY outcome
Timeframe: 4 weeksThe Epworth Sleepiness Scale (ESS) is an 8-question survey assessing symptoms of daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater severity of daytime sleepiness. Thus, a negative change indicates improvement in daytime sleepiness. The ESS has been validated for use in the general population and in PD. Administered at start of treatment period 1, end of treatment period 1, start of treatment period 2, and end of treatment period 2.
Outcome measures
| Measure |
Suvorexant Period
n=19 Participants
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=19 Participants
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS)
|
-0.5 units on a scale
Interval -3.0 to 1.0
|
0.0 units on a scale
Interval -1.0 to 2.0
|
SECONDARY outcome
Timeframe: 4 weeksThe Subject's Global Impression of Change (SGI-C) is a rating scale that asks a single question: "Since baseline (when first starting this study), how have your sleep symptoms changed?" Answers will be on a 7-point scale: 1 = much improved; 2 = somewhat improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = somewhat worse; and 7 = much worse. Evaluated at end of treatment period 1 and end of treatment period 2.
Outcome measures
| Measure |
Suvorexant Period
n=19 Participants
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=19 Participants
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Subject's Global Impression of Change (SGI-C)
|
3 score on a scale
Interval 2.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: 4 weeksThe Clinician's Global Impression of Change (CGI-C) is a rating scale that asks the single question: "Since baseline (when first starting this study), how have the subject's sleep symptoms changed?" Answers will be on a 7-point scale: 1 = much improved; 2 = somewhat improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = somewhat worse; and 7 = much worse.
Outcome measures
| Measure |
Suvorexant Period
n=19 Participants
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=19 Participants
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Clinician's Global Impression of Change (CGI-C)
|
3 score on a scale
Interval 2.0 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
Adverse Events
Suvorexant
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Suvorexant
n=21 participants at risk
All subjects assessed during suvorexant period, regardless of whether they received suvorexant in treatment period 1 or treatment period 2.
|
Placebo
n=21 participants at risk
All Subjects assessed during placebo treatment, regardless of whether this was treatment period 1 or treatment period 2
|
|---|---|---|
|
Nervous system disorders
Excessive Drowsiness
|
9.5%
2/21 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
9.5%
2/21 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
4.8%
1/21 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
1/21 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
0.00%
0/21 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
|
Nervous system disorders
Compulsive behavior
|
0.00%
0/21 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
4.8%
1/21 • Number of events 2 • Adverse event data for each subject was recorded over the duration of their participation in the study, which was 11-15 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place