At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 46 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia: A Randomized Placebo-Controlled Crossover Trial
In Brief
A Phase 4 clinical trial evaluating Suvorexant and Placebo for Restless Legs Syndrome and 2 related conditions. Completed, enrolled 46 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome, Insomnia, Sleep Disorder
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartAug 2021
Primary CompletionOct 2023
TodayJul 2026
First PostedJan 12, 2021
Enrollment StartAug 12, 2021
Primary CompletionOct 20, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.5 years ago
Interventions
Suvorexantdrug
10-mg or 20-mg suvorexant capsules
Placeboother
Matching placebo capsules