Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diego García-Borreguero, MD, PhD; Rocío Prieto Pérez
• Collaborators: Diego Garcia-Borreguero, Paseo de la Habana 151, Madrid 28036, SPAIN; Sleep Research Institute (Paseo de la Habana 151, Madrid 28036, SPAIN)
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

• Idiopathic RLS, according to diagnostic criteria established by the International RLS Study Group (Allen et al., 2003).

• A history (if currently controlled on medication) or the presence of RLS symptoms causing insomnia/ sleep disturbance on 3 or more days per week for at least 12 months.

• Both treatment-naïve and treated patients without a sufficient response will be included. In both of these groups, the IRLS score ≥20 at the screening assessment (for the latter group, measured under current treatment), with an absence of significant RLS symptoms before 9PM (measured by diary)

• Aged 18 - 80 years.

• PSG at baseline containing:

• WASO≥ 60 minutes

• PLMAI of ≥ 15

• TST<6.6hours

• Women of childbearing potential must have a negative pregnancy test at screen and must agree not to become pregnant.

• Prior to any study-specific procedures, a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

• Any secondary forms of RLS.

• History or current diagnosis of other clinically relevant diseases that may confound assessments or RLS symptoms.

• Serum ferritin <18 mcg/ml

• If the patient is currently being treated with drugs likely to influence sleep architecture or motor manifestations during sleep (such as neuroleptics, L-dopa, dopamine agonists, hypnotics, sedatives, antidepressants, anxiolytics, anticonvulsants, psychostimulant medications, steroids, barbiturates and opiates), a wash-out period of at least > 5 half-lives will be undertaken.

• Employed in shift work (for example, employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts) or irregular sleep-wake schedules.

• Patients who require prescription medication for concurrent conditions which could interfere with efficacy assessments such as dopamine antagonists, serotonin reuptake inhibitors or antihistamines.

• Surgery within 180 days of baseline visit, which in the opinion of the investigator would negatively impact the patient's participation in the study.

• A significant medical or psychiatric disorder.

• Any other clinically significant condition or laboratory assay abnormality, which would interfere with the patient's ability to participate in the study.

• Other severe acute or chronic medical or psychiatric condition or laboratory assay abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and would make the patient inappropriate for entry into this study.

• Pregnancy and breastfeeding.

• Any disorders for which suvorexant is contraindicated, such as: narcolepsy, COPD, sleep apnea, depression, suicidal thoughts, severe hepatic illness.