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| Name | Class |
|---|---|
| Clinical Trial Unit Ente Ospedaliero Cantonale | OTHER |
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Proof of concept, double-blind, randomized, placebo-controlled trial with d-methadone proposed for the first time for use in the treatment of patients diagnosed with primary, moderate to very severe Restless Legs Syndrome (RLS). Its glutamatergic mechanism of action might be effective on RLS arousal pattern and sleep disturbance which highly impair the quality of life of RLS's patients.
Patients will take the study drug/placebo once a day for 30 consecutive days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg d-methadone | Experimental | The experimental drug is a tablet formulation of d-methadone HCl in dose strength of 25 mg. |
|
| Placebo | Placebo Comparator | The placebo is an exact match to the active tablets in size, color and marking without the active ingredient d-methadone HCl. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-methadone | Drug | Patients will take one tablet of 25 mg d-methadone once daily at 6 pm over a period of 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of d-methadone | The percentage of responders to d-methadone treatment. A responder is defined as patient who has ≥ 50% reduction in the International RLS Rating Scale (IRLS-RS) score from baseline to end of the 30-day treatment period. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia severity | Change in insomnia severity from baseline to the end of 10-day dosing period and to end of the treatment period assessed by a using the Insomnia Severity Index (ISI) | 10 and 30 days |
| Change in Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Manconi, Prof. MD | Ente Ospedaliero Cantonale, Neurocenter of Southern Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Center, IRCCS San Raffaele | Milan | Italy | ||||
| Schlaf-Wach-Epilepsie Zentrum, Inselspital |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C000626862 | D-methadone |
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| Placebo | Other | Patients will take one tablet of placebo once daily at 6 pm over a period of 30 days |
|
Change in quality of life from baseline to the end of 10-day dosing period and to end of the treatment period assessed assessed by a using the Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
| 10 and 30 days |
| Periodic limb movements of sleep index | Change in Periodic limb movements of sleep (PLMS) index from baseline to end of 10-day dosing period measured by means of polysomnography recording | 10 days |
| Actigrafic parameters | Change from baseline to the end of 10-day dosing period and to end of the treatment period on Total Sleep Time, Sleep Latency and Sleep Efficacy acquired assessed by actigraphy with measurements performed one week prior to the start of treatment, during the 10-day dosing period and one week at the end of the treatment. | 10 and 30 days |
| Bern |
| Switzerland |
| Neurologie / Schlaflabor Kantonsspital Graubünden | Chur | 7000 | Switzerland |
| Sleep Center, Neurocenter of Southern Switzerland | Lugano | 6900 | Switzerland |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |