Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome

This study has been completed.
Information provided by:
Boehringer Ingelheim Identifier:
First received: September 2, 2005
Last updated: October 31, 2013
Last verified: October 2013
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.

Condition Intervention Phase
Restless Legs Syndrome
Drug: pramipexole
Drug: levodopa in combination with benserazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Frequency of periodic limb movements while in bed (PLM-I) [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in RLS-score [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Changes in sleep quality as assessed in a sleep diary [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Changes in Quality of Life (SF-36) [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Mood changes measured by Hospital Anxiety and Depression Scale (HAD) [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Overall impression assessed by Clinical Global Impression (CGI) [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Incidence and Intensity of Adverse events [ Time Frame: up to 10 weeks ] [ Designated as safety issue: No ]
  • Changes in safety laboratory values [ Time Frame: up to 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: February 2003
Estimated Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT00144209

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
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Schweiz GmbH.
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00144209     History of Changes
Other Study ID Numbers: 248.518 
Study First Received: September 2, 2005
Last Updated: October 31, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic
Dopamine Agonists
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 10, 2016