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

Primary Purpose

Restless Legs Syndrome, Insomnia, Sleep Disorder

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Suvorexant

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men or women of any ethnic origin
  2. Written informed consent is obtained
  3. Speaks and writes in English
  4. A willingness and ability to comply with study procedures
  5. Age 25-85 years
  6. Diagnosis of RLS via Cambridge-Hopkins RLS questionnaire
  7. International Restless Legs Syndrome Study Group scale score (IRLS) < 15
  8. RLS treatment with a dopaminergic agonist or an alpha-2-delta agent
  9. No changes in RLS medication in the previous month
  10. DSM-5 criteria for Insomnia Disorder
  11. Report a total sleep time ≤ 7 hours and wake after sleep onset (WASO) > 45 minutes on 7 or more of the 14 nightly sleep logs during both the initial 2-week screening period and the two-week screening run-in period. WASO does not decrease by more than 50% on the 2-week sleep diary obtained between the screening visit and the randomization visit

Exclusion Criteria:

  1. Diagnosis of moderate/severe obstructive sleep apnea (AHI > 30) not using continuous positive airway pressure therapy (CPAP) (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy)
  2. Shift workers
  3. Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period
  4. Unwillingness to maintain stable RLS medication during the study unless medically indicated
  5. Current use of an opiate medication
  6. Unwillingness to not take stimulants (e.g. caffeine) after 4:00 pm during the study
  7. Current major depressive episode, by report and as indicated by the Patient Health Questionnaire (PHQ-9)
  8. Lifetime history of bipolar disorder, psychosis, or other serious psychiatric illness
  9. Current alcohol/substance use disorder
  10. BMI ≥ 40 kg/m^2
  11. Renal or hepatic disease judged to interfere with drug metabolism and excretion
  12. Pregnancy or breastfeeding
  13. Malignancy within past 2 years
  14. Surgery within past 3 months
  15. Neurological disorder or cardiovascular disease raising safety concerns about use of suvorexant and/or judged to interfere with ability to assess efficacy of the treatment
  16. Medical instability considered to interfere with study procedures
  17. Concomitant medications with drug interaction or co-administration concerns
  18. Contraindications or allergic responses to suvorexant
  19. History of being treated with suvorexant
  20. Travel across two time-zones during the week prior to enrollment
  21. Greater than 6 cups of coffee per day

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment --> Placebo

Placebo --> Treatment

Arm Description

This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase.

This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase.

Outcomes

Primary Outcome Measures

Actigraphically-Derived Total Sleep Time
Total sleep time as measured by actigraphy

Secondary Outcome Measures

Actigraphically-Derived Wake After Sleep Onset
Wake after sleep onset as measured by actigraphy
Insomnia Severity Index
A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity

Full Information

First Posted
January 9, 2021
Last Updated
October 23, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04706091
Brief Title
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
Official Title
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia: A Randomized Placebo-Controlled Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
October 20, 2023 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time in patients with effectively treated restless legs syndrome with persistent insomnia in a two-arm, double-blind, randomized placebo-controlled crossover 2.5-month trial.
Detailed Description
Restless Legs Syndrome (RLS) is a sensory-motor neurological disorder characterized by an irresistible urge to move the legs. Persistent difficulties with all phases of sleep are common in patients whose RLS symptoms are resolved with treatment. Multiple potential causes for treatment-refractory sleep disturbance exist, including activating effects of dopamine agonists (which are first-line RLS treatments), conditioned insomnia and poor sleep habits as a result of chronic RLS-related sleep disturbance, and comorbid medical and psychiatric illness. Suvorexant provides an important therapeutic option to treat insomnia in the context of RLS. It has demonstrated long-term efficacy, particularly in shortening the duration of nocturnal awakenings and increasing total sleep time. Similarly, it has a comparatively benign side effect profile compared to many other agents typically prescribed to treat insomnia. The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time, as well as actigraphically-derived wake after sleep onset, Insomnia Severity Index score, subjective sleep endpoints, and RLS symptom severity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Insomnia, Sleep Disorder
Keywords
Suvorexant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Subjects will be randomized in a 1:1 ratio to suvorexant 10-20 mg or equivalent placebo for four weeks followed by crossover (after a 2-week washout) to the alternate treatment.
Masking
ParticipantInvestigator
Masking Description
The participant, investigator, and clinical research coordinator will remain masked throughout the duration of the study.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment --> Placebo
Arm Type
Experimental
Arm Description
This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase.
Arm Title
Placebo --> Treatment
Arm Type
Experimental
Arm Description
This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase.
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Other Intervention Name(s)
Belsomra
Intervention Description
10-mg or 20-mg suvorexant capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules
Primary Outcome Measure Information:
Title
Actigraphically-Derived Total Sleep Time
Description
Total sleep time as measured by actigraphy
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Actigraphically-Derived Wake After Sleep Onset
Description
Wake after sleep onset as measured by actigraphy
Time Frame
2 weeks
Title
Insomnia Severity Index
Description
A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Diary-Derived Wake After Sleep Onset
Description
Wake after sleep onset as reported on daily sleep diaries
Time Frame
2 weeks
Title
Diary-Derived Total Sleep Time
Description
Total sleep time as reported on daily sleep diaries
Time Frame
2 weeks
Title
Diary-derived Sleep Onset Latency, Sleep Efficiency and Sleep Quality
Description
Sleep onset latency, sleep efficiency and sleep quality as reported on daily sleep diaries
Time Frame
2 weeks
Title
International Restless Legs Syndrome Study Group Scale
Description
A validated tool to measure restless legs syndrome severity, on a scale of 0-40, with a higher score representing greater restless legs syndrome severity
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women of any ethnic origin Written informed consent is obtained Speaks and writes in English A willingness and ability to comply with study procedures Age 25-85 years Diagnosis of RLS via Cambridge-Hopkins RLS questionnaire International Restless Legs Syndrome Study Group scale score (IRLS) < 15 RLS treatment with a dopaminergic agonist or an alpha-2-delta agent No changes in RLS medication in the previous month DSM-5 criteria for Insomnia Disorder Report a total sleep time ≤ 7 hours and wake after sleep onset (WASO) > 45 minutes on 7 or more of the 14 nightly sleep logs during both the initial 2-week screening period and the two-week screening run-in period. WASO does not decrease by more than 50% on the 2-week sleep diary obtained between the screening visit and the randomization visit Exclusion Criteria: Diagnosis of moderate/severe obstructive sleep apnea (AHI > 30) not using continuous positive airway pressure therapy (CPAP) (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy) Shift workers Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period Unwillingness to maintain stable RLS medication during the study unless medically indicated Current use of an opiate medication Unwillingness to not take stimulants (e.g. caffeine) after 4:00 pm during the study Current major depressive episode, by report and as indicated by the Patient Health Questionnaire (PHQ-9) Lifetime history of bipolar disorder, psychosis, or other serious psychiatric illness Current alcohol/substance use disorder BMI ≥ 40 kg/m^2 Renal or hepatic disease judged to interfere with drug metabolism and excretion Pregnancy or breastfeeding Malignancy within past 2 years Surgery within past 3 months Neurological disorder or cardiovascular disease raising safety concerns about use of suvorexant and/or judged to interfere with ability to assess efficacy of the treatment Medical instability considered to interfere with study procedures Concomitant medications with drug interaction or co-administration concerns Contraindications or allergic responses to suvorexant History of being treated with suvorexant Travel across two time-zones during the week prior to enrollment Greater than 6 cups of coffee per day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Winkelman, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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