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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144209
• Other study ID #: 248.518
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: October 31, 2013
• Start date: February 2003
• Est. completion date: February 2005

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• pramipexole

• levodopa in combination with benserazide

Locations

Country	Name	City	State
Switzerland	Boehringer Ingelheim Investigational Site	Basel
Switzerland	Boehringer Ingelheim Investigational Site	Basel
Switzerland	Boehringer Ingelheim Investigational Site	Bern
Switzerland	Boehringer Ingelheim Investigational Site	Lugano
Switzerland	Boehringer Ingelheim Investigational Site	Zurich
Switzerland	Boehringer Ingelheim Investigational Site	Zurzach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of periodic limb movements while in bed (PLM-I)		after 4 weeks	No
Secondary	Changes in RLS-score		after 4 weeks	No
Secondary	Changes in sleep quality as assessed in a sleep diary		after 4 weeks	No
Secondary	Changes in Quality of Life (SF-36)		after 4 weeks	No
Secondary	Mood changes measured by Hospital Anxiety and Depression Scale (HAD)		after 4 weeks	No
Secondary	Overall impression assessed by Clinical Global Impression (CGI)		after 4 weeks	No
Secondary	Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)		after 4 weeks	No
Secondary	Incidence and Intensity of Adverse events		up to 10 weeks	No
Secondary	Changes in safety laboratory values		up to 10 weeks	No

External Links

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