Status:
COMPLETED
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Restless Legs Syndrome
Insomnia
Eligibility:
All Genders
25-85 years
Phase:
PHASE4
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-ar...
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04706091
Start Date
August 12 2021
End Date
October 20 2023
Last Update
January 16 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114