NCT00144209|CompletedPhase 3

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

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

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

248.518

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredSep 2005

StartedFeb 2003

CompletionFeb 2005

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Feb 2003

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

February 1, 2003

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed

Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

September 2, 2005

Last Update Submit

October 31, 2013

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

Frequency of periodic limb movements while in bed (PLM-I)
after 4 weeks

Secondary Outcomes (8)

Changes in RLS-score
after 4 weeks
Changes in sleep quality as assessed in a sleep diary
after 4 weeks
Changes in Quality of Life (SF-36)
after 4 weeks
Mood changes measured by Hospital Anxiety and Depression Scale (HAD)
after 4 weeks
Overall impression assessed by Clinical Global Impression (CGI)
after 4 weeks
+3 more secondary outcomes

Interventions

pramipexoleDRUG

levodopa in combination with benserazideDRUG

Eligibility Criteria

Age25 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.