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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Restless Legs Syndrome	Drug: pramipexole; Drug: levodopa in combination with benserazide	Phase 3

Study Design

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Frequency of periodic limb movements while in bed (PLM-I) [ Time Frame: after 4 weeks ]

Secondary Outcome Measures :

1. Changes in RLS-score [ Time Frame: after 4 weeks ]
2. Changes in sleep quality as assessed in a sleep diary [ Time Frame: after 4 weeks ]
3. Changes in Quality of Life (SF-36) [ Time Frame: after 4 weeks ]
4. Mood changes measured by Hospital Anxiety and Depression Scale (HAD) [ Time Frame: after 4 weeks ]
5. Overall impression assessed by Clinical Global Impression (CGI) [ Time Frame: after 4 weeks ]
6. Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: after 4 weeks ]
7. Incidence and Intensity of Adverse events [ Time Frame: up to 10 weeks ]
8. Changes in safety laboratory values [ Time Frame: up to 10 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	25 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair:	Boehringer Ingelheim Study Coordinator	B.I. Schweiz GmbH.

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

ClinicalTrials.gov Identifier:	NCT00144209 History of Changes
Other Study ID Numbers:	248.518
First Posted:	September 5, 2005
Last Update Posted:	November 1, 2013
Last Verified:	October 2013

Additional relevant MeSH terms:

Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Disease; Pathologic Processes; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias	Mental Disorders; Levodopa; Pramipexole; Benserazide; Dopamine; Benserazide, levodopa drug combination; Dopamine Agonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Cardiotonic Agents; Sympathomimetics