A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo
NCT ID: NCT04145674
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2022-10-22
2025-12-30
Brief Summary
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Patients will take the study drug/placebo once a day for 30 consecutive days.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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25 mg d-methadone
The experimental drug is a tablet formulation of d-methadone HCl in dose strength of 25 mg.
D-methadone
Patients will take one tablet of 25 mg d-methadone once daily at 6 pm over a period of 30 days
Placebo
The placebo is an exact match to the active tablets in size, color and marking without the active ingredient d-methadone HCl.
Placebo
Patients will take one tablet of placebo once daily at 6 pm over a period of 30 days
Interventions
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D-methadone
Patients will take one tablet of 25 mg d-methadone once daily at 6 pm over a period of 30 days
Placebo
Patients will take one tablet of placebo once daily at 6 pm over a period of 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to very severe RLS defined as IRLS-RS score \> 10.
* Written informed consent.
* Willingness and ability to participate in the trial
Exclusion Criteria
* 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 dopamine agonists and opioids (wash-out period: at least 7 days).
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Clinical Trial Unit Ente Ospedaliero Cantonale
OTHER
Mauro Manconi
OTHER
Responsible Party
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Mauro Manconi
Prof. MD
Principal Investigators
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Mauro Manconi, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Ente Ospedaliero Cantonale, Neurocenter of Southern Switzerland
Locations
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Sleep Center, IRCCS San Raffaele
Milan, , Italy
Schlaf-Wach-Epilepsie Zentrum, Inselspital
Bern, , Switzerland
Neurologie / Schlaflabor Kantonsspital Graubünden
Chur, , Switzerland
Sleep Center, Neurocenter of Southern Switzerland
Lugano, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NSI-RLS-001
Identifier Type: -
Identifier Source: org_study_id
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