Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome
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ClinicalTrials.gov Identifier: NCT00144209 |
Recruitment Status :
Completed
First Posted : September 5, 2005
Last Update Posted : November 1, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Restless Legs Syndrome | Drug: pramipexole Drug: levodopa in combination with benserazide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Swiss Restless Legs Syndrome Trial (SRLS) A Double-blind, Randomised, Crossover Trial Investigating the Efficacy and Safety of the Dopamine Agonist Pramipexole (Sifrol®, 0.25-0.75 mg Per Day) Versus Levodopa / Benserazide (Madopar® DR, 125-375 mg Per Day) in Patients With Restless Legs Syndrome |
Study Start Date : | February 2003 |
Actual Primary Completion Date : | February 2005 |
Study Completion Date : | February 2005 |

- Frequency of periodic limb movements while in bed (PLM-I) [ Time Frame: after 4 weeks ]
- Changes in RLS-score [ Time Frame: after 4 weeks ]
- Changes in sleep quality as assessed in a sleep diary [ Time Frame: after 4 weeks ]
- Changes in Quality of Life (SF-36) [ Time Frame: after 4 weeks ]
- Mood changes measured by Hospital Anxiety and Depression Scale (HAD) [ Time Frame: after 4 weeks ]
- Overall impression assessed by Clinical Global Impression (CGI) [ Time Frame: after 4 weeks ]
- Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: after 4 weeks ]
- Incidence and Intensity of Adverse events [ Time Frame: up to 10 weeks ]
- Changes in safety laboratory values [ Time Frame: up to 10 weeks ]

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Ages Eligible for Study: | 25 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients diagnosed with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria 1 .
- Male or female patients, aged 25 to 85 years.
- Patients presenting RLS symptoms almost every day, as judged by the investigator and with more than 5 PLM/h during bedtime in each of three screening actigraphy nights.
- Patients must have given written informed consent in accordance with ICH-GCP and local legislation prior to participation in the study.
Exclusion criteria:
- Patients with significant diseases other than restless legs syndrome will be excluded. A significant disease is defined as a disease that, which in the opinion of the investigator may put the patient at a risk because of the participation in the study, that may influence the result of the study or the patient's ability to participate or that is expected to relevantly reduce life expectancy.
- Patients with known hypersensitivity or contraindications to pramipexole, levodopa or benserazide or any other substances present in the study medications.
- Patients with iron-deficiency
- Patients with disabilities or other incapacities that preclude regular attendance at clinic for the study visits, and patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.
- Patients who have been previously treated with pramipexole or levodopa.
- Pregnant or nursing women or women of childbearing age who are at risk of pregnancy and are not willing to use adequate contraceptive methods (hormonal contraception or intrauterine devices) during the study period.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144209
Switzerland | |
Boehringer Ingelheim Investigational Site | |
Basel, Switzerland, 4025 | |
Boehringer Ingelheim Investigational Site | |
Basel, Switzerland, 4031 | |
Boehringer Ingelheim Investigational Site | |
Bern, Switzerland, 3000 | |
Boehringer Ingelheim Investigational Site | |
Lugano, Switzerland, CH-6900 | |
Boehringer Ingelheim Investigational Site | |
Zurich, Switzerland, 8091 | |
Boehringer Ingelheim Investigational Site | |
Zurzach, Switzerland, 5330 |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Schweiz GmbH. |
ClinicalTrials.gov Identifier: | NCT00144209 |
Other Study ID Numbers: |
248.518 |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | November 1, 2013 |
Last Verified: | October 2013 |
Psychomotor Agitation Restless Legs Syndrome Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Parasomnias |
Mental Disorders Levodopa Pramipexole Benserazide Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antioxidants Protective Agents Dopamine Agonists Enzyme Inhibitors |