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Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

NCT03755310 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-11-29

No results posted yet for this study

Summary

Suvorexant improves sleep latency and wake after sleep onset in patients with primary insomnia, and is FDA approved for this condition.

However, no data exist on its effects in RLS, so far. The investigators consider that suvorexant might provide a stable therapeutic efficacy for the long treatment, avoiding the risk of augmentation of symptoms commonly seen under dopamine agonists.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Suvorexant

First week: 10 mg tabs; Second week: 10-20 mg tabs

DRUG

Placebo

Equivalent dosage, route of administration and dose regimen

Sponsors & Collaborators

  • Sleep Research Institute (Paseo de la Habana 151, Madrid 28036, SPAIN)

    collaborator UNKNOWN

  • Diego García-Borreguero, MD, PhD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03755310 on ClinicalTrials.gov