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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
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 ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
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.
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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

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

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Benserazide, levodopa drug combination
Dopamine Agonists
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017