Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant

NCT03755310 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: IISP-57325
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change (differences between visits 2 and 5) in Wake Time After Sleep Onset (WASO), as measured during polysomnography

  1 year

Secondary Outcomes (6)

• Change (differences between visits 2 and 5) in International Restless Legs Scale (IRLS)

  1 year

• Change (differences between visits 2 and 5) in Clinical Global Impressions (CGI)

  1 year

• Change (differences between visits 2 and 5) in Total Sleep Time (TST)

  1 year

• Change (differences between visits 2 and 5) in Periodic Leg Movement during Sleep-index (PLMS)

  1 year

• Change (differences between visits 2 and 5) in Periodic Leg movement while awake-index (PLMW-index)

  1 year

Study Arms (2)

Suvorexant

EXPERIMENTAL

10mg tabs during the first week, 10-20 mg tabs on the second week.

Drug: Suvorexant

Placebo

PLACEBO COMPARATOR

Equivalent dosage, route of administration and dose regimen.

Drug: Placebo

Interventions

Suvorexant DRUG

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

Suvorexant

Placebo DRUG

Equivalent dosage, route of administration and dose regimen

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diego García-Borreguero, MD, PhD: lead
• Sleep Research Institute (Paseo de la Habana 151, Madrid 28036, SPAIN): collaborator

Study Sites (1)

Sleep Research Institute; Paseo de la Habana 151

Madrid, 28036, Spain

Location

Related Publications (1)

• 1. Sleep Med 2014;15(8):860-73. 2. Sleep Med. 2013;14(7):675-84. 3. Sleep Med 2012;13:1280-5. 4. Sleep Med 2011;12:440-4. 5. Sleep Med 2015;16(10):1252-8. 6. Sleep Med. 2016;21:1-11. 7. Sleep Med Clin 2015;10:207-14, xi. 8. Sleep Med. 2009;10(1):134-8. 9. Neurology. 2013;80(22):2028-34 10. Neurosci Biobehav Rev. 2015;49:43-54. 11. Peptides. 2014;52:29-37. 12. Curr Biol. 2013;23(18):1719-25. 13. Curr Opin Neurobiol. 2013;23(5):752-9. 14. Neurosci Bull. 2013;29(3):355-65. 15. Neurology. 2002;59(4):639-

  BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Central Study Contacts

Diego García-Borreguero, MD. PhD.

CONTACT

+34 913 454 129; dgb@iis.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sleep Research Institute

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: November 27, 2018
• Study Start: February 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

ES (1)