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

NCT ID: NCT00144209

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pramipexole

Intervention Type DRUG

levodopa in combination with benserazide

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Schweiz GmbH.

Locations

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Boehringer Ingelheim Investigational Site

Bad Zurzach, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Basel, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Basel, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Bern, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Lugano, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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. eCollection 2011.

Reference Type DERIVED
PMID: 22101745 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21060282 (View on PubMed)

Other Identifiers

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248.518

Identifier Type: -

Identifier Source: org_study_id