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

NCT04706091 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2020P003535
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome; Insomnia; Sleep Disorder

Keywords

Suvorexant

Outcome Measures

Primary Outcomes (1)

• Actigraphically-Derived Total Sleep Time

  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.

  2 weeks

Secondary Outcomes (2)

• Actigraphically-Derived Wake After Sleep Onset

  2 weeks

• Insomnia Severity Index

  2 weeks

Study Arms (2)

Treatment --> Placebo

EXPERIMENTAL

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

Drug: Suvorexant; Other: Placebo

Placebo --> Treatment

EXPERIMENTAL

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

Drug: Suvorexant; Other: Placebo

Interventions

Suvorexant DRUG

10-mg or 20-mg suvorexant capsules

Also known as: Belsomra

Placebo --> Treatment; Treatment --> Placebo

Placebo OTHER

Matching placebo capsules

Placebo --> Treatment; Treatment --> Placebo

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Winkelman JW, Zackon J, Kilty A. Improvement in self-reported, but not actigraphic, sleep measures with suvorexant in people with well-controlled Restless Legs Syndrome and persistent insomnia. Sleep Med. 2024 Dec;124:30-37. doi: 10.1016/j.sleep.2024.09.005. Epub 2024 Sep 8.

  PMID: 39260076 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John W Winkelman, MD PhD
• Organization: Massachusetts General Hospital

jwwinkelman@mgh.harvard.edu

617-724-7426

Study Officials

• John W Winkelman, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant, investigator, and clinical research coordinator will remain masked throughout the duration of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Sleep Disorders Clinical Research Program

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 12, 2021
• Study Start: August 12, 2021
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)