A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo

• Status: Not yet recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Proof of concept, double-blind Randomized Controlled Trial with d-Methadone proposed for the first time for use in the treatment of patients diagnosed with primary, moderate to very severe RLS. Its glutamatergic mechanism of action might be effective on Restless Legs Syndrome arousal pattern and sleep disturbance which highly impair the quality of life of Restless Legs Syndrome's patients.

Patients must take study drug once a day for 10 consecutive days.

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

Details

• Lead Sponsor: Mauro Manconi
• Collaborator: Clinical Trial Unit Ente Ospedaliero Cantonale
• Treatments: D-methadone; Methadone

Criteria

Inclusion Criteria:

• Diagnosis of primary RLS.

• Moderate to very severe RLS defined as IRLS-RS score > 10.

• PLMS index ≥ 15 as assessed by V-PSG.

• Written informed consent.

• Willingness and ability to participate in the trial

Exclusion Criteria:

• Positive history of known causes of secondary RLS.

• Any other concomitant treatment for RLS (wash-out period: at least 7 days).

• Moderate-severe sleep apnea defined as Apnea Hypopnea Index ≥ 15.

• History or presence of clinically significant abnormality as assessed by neurological examination which in the opinion of the Investigator would jeopardize the safety of the patients or the validity of the study results.

• Evidence of clinically significant hepatic or renal impairment

• History or family history of sudden unexplained death or long QT syndrome.

• Any 12-lead ECG with demonstration of QTc ≥ 450 msec or a QRS interval ≥ 120 msec at Screening.

• Concomitant use of psycho-drugs

• History or presence of any condition in which an opioid is contraindicated

• History of allergy or hypersensitivity to methadone or related drugs.

• Any clinically significant neurological, sleep, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, chronic pain, psychiatric or gastrointestinal disorder.

• Women who are pregnant or breast feeding.

• Inability to follow the procedures of the study, (e.g. due to language problems, psychological disorders, dementia, etc. of the participant).

• Previous enrolment into the current study.

• Enrolment of the investigator, his/her family members, employees and other dependent persons.

• Participation in another study with investigational drug within the 30 days preceding and during the present study.