Trial Outcomes & Findings for Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia (NCT NCT04706091)

Last Updated: 2024-01-16

Results Overview

Change in mean total sleep time (between baseline and end of treatment, for each treatment period), as measured by actigraphy. Participants wear an actigraph watch, which assesses periods of activity and rest to determine the total amount of sleep during one sleep period. Total sleep time excludes sleep onset latency and nighttime awakenings.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

2 weeks

Results posted on

2024-01-16

Participant Flow

Prior to signing an Informed Consent Form (ICF), participants complete Sleep Diaries. If eligible, they sign the ICF, followed by additional Sleep Diaries. During this second period, 8 enrolled participants were excluded from the study for the following reasons: sleep no longer met criteria (4), RLS was too severe (2), sleep apnea (1), no RLS (1). Four participants withdrew from the study due to: unrelated surgery (2), no longer interested (1), lost to follow-up (1).

Participant milestones

Participant milestones
Measure	Treatment --> Placebo This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules	Placebo --> Treatment This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules
Treatment 1 STARTED	18	16
Treatment 1 COMPLETED	18	16
Treatment 1 NOT COMPLETED	0	0
Treatment 2 STARTED	17	16
Treatment 2 COMPLETED	16	16
Treatment 2 NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment --> Placebo This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules	Placebo --> Treatment This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules
Treatment 2 Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment --> Placebo n=18 Participants This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules	Placebo --> Treatment n=16 Participants This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules	Total n=34 Participants Total of all reporting groups
Age, Continuous	65.7 years STANDARD_DEVIATION 7.7 • n=5 Participants	59.3 years STANDARD_DEVIATION 10.9 • n=7 Participants	62.7 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	18 Participants n=5 Participants	16 Participants n=7 Participants	34 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	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
BMI	29.0 kg/m^2 STANDARD_DEVIATION 10.1 • n=5 Participants	27.0 kg/m^2 STANDARD_DEVIATION 4.8 • n=7 Participants	28.1 kg/m^2 STANDARD_DEVIATION 8.0 • n=5 Participants
International Restless Legs Syndrome Study Group Rating Scale (IRLS)	8.3 units on a scale (0-40) STANDARD_DEVIATION 5.9 • n=5 Participants	8.1 units on a scale (0-40) STANDARD_DEVIATION 4.5 • n=7 Participants	8.2 units on a scale (0-40) STANDARD_DEVIATION 5.2 • n=5 Participants
Insomnia Severity Index (ISI)	16 units on a scale (0-28) STANDARD_DEVIATION 3.9 • n=5 Participants	14.2 units on a scale (0-28) STANDARD_DEVIATION 3.8 • n=7 Participants	15.1 units on a scale (0-28) STANDARD_DEVIATION 3.9 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Two participants in the Treatment --\> Placebo arm of the study withdrew prior to treatment period 2.

Outcome measures

Outcome measures
Measure	Treatment --> Placebo n=18 Participants This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules	Placebo --> Treatment n=16 Participants This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules
Actigraphically-Derived Total Sleep Time Treatment 1	5.03 Minutes Standard Deviation 40.80	11.44 Minutes Standard Deviation 24.16
Actigraphically-Derived Total Sleep Time Treatment 2	7.60 Minutes Standard Deviation 53.01	17.96 Minutes Standard Deviation 32.04

SECONDARY outcome

Timeframe: 2 weeks

Population: Two participants in the Treatment --\> Placebo arm withdrew from the study prior to treatment period 2.

Change in wake after sleep onset (between baseline and end of treatment, for each treatment period), as measured by actigraphy. Participants wear an actigraph watch, which assesses periods of activity and rest to determine the total wake time after sleep onset, during nighttime awakenings.

Outcome measures

Outcome measures
Measure	Treatment --> Placebo n=18 Participants This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules	Placebo --> Treatment n=16 Participants This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules
Actigraphically-Derived Wake After Sleep Onset Treatment 1	0.88 Minutes Standard Deviation 14.26	-0.67 Minutes Standard Deviation 19.53
Actigraphically-Derived Wake After Sleep Onset Treatment 2	-1.05 Minutes Standard Deviation 15.59	-1.20 Minutes Standard Deviation 12.05

SECONDARY outcome

Timeframe: 2 weeks

Population: Two participants in the Treatment --\> Placebo arm withdrew from the study prior to treatment period 2.

Change in ISI score between baseline and end of treatment, for each treatment period. The ISI is a validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.

Outcome measures

Outcome measures
Measure	Treatment --> Placebo n=18 Participants This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules	Placebo --> Treatment n=16 Participants This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase. Suvorexant: 10-mg or 20-mg suvorexant capsules Placebo: Matching placebo capsules
Insomnia Severity Index Treatment 1	-4.78 units on a scale Standard Deviation 4.62	-1.25 units on a scale Standard Deviation 5.30
Insomnia Severity Index Treatment 2	-4.29 units on a scale Standard Deviation 5.30	-5.69 units on a scale Standard Deviation 6.87

Adverse Events

Suvorexant

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Suvorexant n=34 participants at risk Participants in both arms of the study received suvorexant treatment, either during treatment one or treatment two.	Placebo n=32 participants at risk Participants in both arms of the study received placebo treatment, either during treatment one or treatment two.
General disorders Fatigue	29.4% 10/34 • AE data were collected during the two treatment periods, for a total of 8 weeks.	9.4% 3/32 • AE data were collected during the two treatment periods, for a total of 8 weeks.
Psychiatric disorders Vivid Dreams	8.8% 3/34 • AE data were collected during the two treatment periods, for a total of 8 weeks.	3.1% 1/32 • AE data were collected during the two treatment periods, for a total of 8 weeks.
Nervous system disorders Worsened RLS	8.8% 3/34 • AE data were collected during the two treatment periods, for a total of 8 weeks.	18.8% 6/32 • AE data were collected during the two treatment periods, for a total of 8 weeks.
General disorders Headache	5.9% 2/34 • AE data were collected during the two treatment periods, for a total of 8 weeks.	12.5% 4/32 • AE data were collected during the two treatment periods, for a total of 8 weeks.
Psychiatric disorders Mood Alteration (Depression/Anxiety/Irritability)	5.9% 2/34 • AE data were collected during the two treatment periods, for a total of 8 weeks.	9.4% 3/32 • AE data were collected during the two treatment periods, for a total of 8 weeks.
Psychiatric disorders Worsened Insomnia	5.9% 2/34 • AE data were collected during the two treatment periods, for a total of 8 weeks.	9.4% 3/32 • AE data were collected during the two treatment periods, for a total of 8 weeks.

Additional Information

John W Winkelman, MD PhD

Massachusetts General Hospital

Phone: 617-724-7426

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place