Phase 4
N=34
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
Restless Legs Syndrome · Insomnia · Sleep Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04706091 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Actigraphically-Derived Total Sleep Time — 5.03; 11.44; 7.60; 17.96 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Suvorexant (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actigraphically-Derived Total Sleep Time |
5.03; 11.44; 7.60; 17.96 | — |
| SECONDARY Actigraphically-Derived Wake After Sleep Onset |
0.88; -0.67; -1.05; -1.20 | — |
| SECONDARY Insomnia Severity Index |
-4.78; -1.25; -4.29; -5.69 | — |
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.
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) 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
Data sourced from ClinicalTrials.gov (NCT04706091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.