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The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cabergoline | Drug | Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS) | Week 6 | |
| Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period) |
| Measure | Description | Time Frame |
|---|---|---|
| RLS quality-of-life questionnaire | Weeks 6 and 30 | |
| Clinical Global Impression | Weeks 6 and 30 | |
| Patient Global Impression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Innsbruck | 6020 | Austria | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| levodopa | Drug | Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events |
|
| Weeks 6 and 30 |
| Sleep questionnaire form A | Weeks 6 and 30 |
| IRLSSG-RS | Week 30 |
| Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram | Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2 |
| Rating of severity of RLS at night (RLS-6 scale) | Weeks 6 and 30 |
| Rating of severity of RLS before bedtime (RLS-6 scale) | Weeks 6 and 30 |
| Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales) | Weeks 6 and 30 |
| Global rating of quality of sleep (RLS-6 scale) | Weeks 6 and 30 |
| Vienna |
| A-1090 |
| Austria |
| Pfizer Investigational Site | Altötting | 84503 | Germany |
| Pfizer Investigational Site | Aschaffenburg | 63739 | Germany |
| Pfizer Investigational Site | Bad Honnef | 53604 | Germany |
| Pfizer Investigational Site | Bad Saarow | 15526 | Germany |
| Pfizer Investigational Site | Beckum | 49269 | Germany |
| Pfizer Investigational Site | Berlin | 10969 | Germany |
| Pfizer Investigational Site | Berlin | 12163 | Germany |
| Pfizer Investigational Site | Berlin | 12687 | Germany |
| Pfizer Investigational Site | Berlin | 13053 | Germany |
| Pfizer Investigational Site | Berlin | 13507 | Germany |
| Pfizer Investigational Site | Bochum | Germany |
| Pfizer Investigational Site | Bremerhaven | 27568 | Germany |
| Pfizer Investigational Site | Dillingen | 66763 | Germany |
| Pfizer Investigational Site | Duisburg | Germany |
| Pfizer Investigational Site | Düsseldorf | 40211 | Germany |
| Pfizer Investigational Site | Gelsenkirchen | 45891 | Germany |
| Pfizer Investigational Site | Gera | 0755 | Germany |
| Pfizer Investigational Site | Göttingen | 37037 | Germany |
| Pfizer Investigational Site | Göttingen | 37075 | Germany |
| Pfizer Investigational Site | Halle | 06118 | Germany |
| Pfizer Investigational Site | Hamburg | 22359 | Germany |
| Pfizer Investigational Site | Heilbronn | 74072 | Germany |
| Pfizer Investigational Site | Jena | Germany |
| Pfizer Investigational Site | Kaiserslautern | 67655 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76137 | Germany |
| Pfizer Investigational Site | Karlsruhe | Germany |
| Pfizer Investigational Site | Kassel | 34128 | Germany |
| Pfizer Investigational Site | Köthen | Germany |
| Pfizer Investigational Site | Marburg | 35039 | Germany |
| Pfizer Investigational Site | Mittweida | 09648 | Germany |
| Pfizer Investigational Site | Mönchengladbach | 41179 | Germany |
| Pfizer Investigational Site | Neubrandenburg | 17033 | Germany |
| Pfizer Investigational Site | Oldenburg | 26122 | Germany |
| Pfizer Investigational Site | Quickborn | 25451 | Germany |
| Pfizer Investigational Site | Regensburg | 93053 | Germany |
| Pfizer Investigational Site | Schwalmstadt | 34613 | Germany |
| Pfizer Investigational Site | Schwerin | 19055 | Germany |
| Pfizer Investigational Site | Stuttgart | 70176 | Germany |
| Pfizer Investigational Site | Tuttlingen | 78532 | Germany |
| Pfizer Investigational Site | Ulm | 89073 | Germany |
| Pfizer Investigational Site | Wiesbaden | 65191 | Germany |
| Pfizer Investigational Site | Wolfsburg | Germany |
| Pfizer Investigational Site | Gothenburg | S-413 45 | Sweden |
| Pfizer Investigational Site | Karlstad | Sweden |
| Pfizer Investigational Site | Linköping | 581 85 | Sweden |
| Pfizer Investigational Site | Basel | Basel | 4031 | Switzerland |
| Pfizer Investigational Site | Bern | Canton of Bern | Switzerland |
| Pfizer Investigational Site | Zurich | CH-8091 | Switzerland |
| 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 |
|---|---|
| D000077465 | Cabergoline |
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| 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 |
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