Trial Outcomes & Findings for A Pilot Study of Suvorexant for Insomnia in Parkinson Disease (NCT 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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-08-20

Participant Flow

Participant milestones

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

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=5 Participants	55.9 years STANDARD_DEVIATION 5.6 • n=7 Participants	60.2 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 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	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Years since diagnosis of Parkinson disease	3.4 years STANDARD_DEVIATION 3.0 • n=5 Participants	3.9 years STANDARD_DEVIATION 2.3 • n=7 Participants	3.7 years STANDARD_DEVIATION 2.7 • n=5 Participants
Levodopa-Equivalent Daily Dose	687.8 mg STANDARD_DEVIATION 336.0 • n=5 Participants	676.9 mg STANDARD_DEVIATION 213.6 • n=7 Participants	682.6 mg STANDARD_DEVIATION 277.5 • n=5 Participants
Hoehn & Yahr Stage	2 Stage n=5 Participants	2 Stage n=7 Participants	2 Stage n=5 Participants
MDS-UPDRS Part 3 Score	24 units on a scale n=5 Participants	24.5 units on a scale n=7 Participants	24 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

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 weeks

Wakefulness 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

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 weeks

Latency 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

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 weeks

The 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

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 weeks

The 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

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 weeks

The 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

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 weeks

The 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

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

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. Daniel Burdick

EvergreenHealth Medical Center

Phone: 4258993108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place