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The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75 mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an objective measure of the leg movements during the time spent in bed, and a quantitative clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramipexole | Drug | |||
| levodopa in combination with benserazide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of periodic limb movements while in bed (PLM-I) | after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in RLS-score | after 4 weeks | |
| Changes in sleep quality as assessed in a sleep diary | after 4 weeks | |
| Changes in Quality of Life (SF-36) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | B.I. Schweiz GmbH. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Bad Zurzach | 5330 | Switzerland | |||
| Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22101745 | Derived | Bassetti CL, Bornatico F, Fuhr P, Schwander J, Kallweit U, Mathis J; Swiss RLS study group. Pramipexole versus dual release levodopa in restless legs syndrome: a double blind, randomised, cross-over trial. Swiss Med Wkly. 2011 Nov 21;141:w13274. doi: 10.4414/smw.2011.13274. eCollection 2011. | |
| 21060282 | Derived |
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| after 4 weeks |
| Mood changes measured by Hospital Anxiety and Depression Scale (HAD) | after 4 weeks |
| Overall impression assessed by Clinical Global Impression (CGI) | after 4 weeks |
| Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) | after 4 weeks |
| Incidence and Intensity of Adverse events | up to 10 weeks |
| Changes in safety laboratory values | up to 10 weeks |
| Basel |
| 4025 |
| Switzerland |
| Boehringer Ingelheim Investigational Site | Basel | 4031 | Switzerland |
| Boehringer Ingelheim Investigational Site | Bern | 3000 | Switzerland |
| Boehringer Ingelheim Investigational Site | Lugano | CH-6900 | Switzerland |
| Boehringer Ingelheim Investigational Site | Zurich | 8091 | Switzerland |
| Kallweit U, Khatami R, Pizza F, Mathis J, Bassetti CL. Dopaminergic treatment in idiopathic restless legs syndrome: effects on subjective sleepiness. Clin Neuropharmacol. 2010 Nov-Dec;33(6):276-8. doi: 10.1097/WNF.0b013e3181fd82a1. |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| D007980 | Levodopa |
| D001545 | Benserazide |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D006834 | Hydrazines |
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