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Restless Legs SyndromePhase 3NCT00144209

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

A Phase 3 study testing pramipexole and levodopa in combination with benserazide in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 6 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 25 to 85 years
Conditions the study is for
Restless Legs Syndrome
What is being tested?
pramipexole and levodopa in combination with benserazide
How many people
58 participants
Where
6 sitesSwitzerland
Study dates
Feb 2003to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Switzerland6 sites

  • Boehringer Ingelheim Investigational Site

    Bad Zurzach, 5330

  • Boehringer Ingelheim Investigational Site

    Basel, 4025

  • Boehringer Ingelheim Investigational Site

    Basel, 4031

  • Boehringer Ingelheim Investigational Site

    Bern, 3000

  • Boehringer Ingelheim Investigational Site

    Lugano, CH-6900

  • Boehringer Ingelheim Investigational Site

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Being tested
pramipexole, levodopa in combination with benserazide
Medical subject headings
Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pramipexoleDrug

  • levodopa in combination with benserazideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of periodic limb movements while in bed (PLM-I)

    Measured: after 4 weeks

Secondary outcomes (8)

  1. Changes in RLS-score

    Measured: after 4 weeks

  2. Changes in sleep quality as assessed in a sleep diary

    Measured: after 4 weeks

  3. Changes in Quality of Life (SF-36)

    Measured: after 4 weeks

  4. Mood changes measured by Hospital Anxiety and Depression Scale (HAD)

    Measured: after 4 weeks

  5. Overall impression assessed by Clinical Global Impression (CGI)

    Measured: after 4 weeks

  6. Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)

    Measured: after 4 weeks

  7. Incidence and Intensity of Adverse events

    Measured: up to 10 weeks

  8. Changes in safety laboratory values

    Measured: up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionFeb 2005
  4. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00144209
Sponsor's protocol ID
248.518
Status last verified
Oct 2013
First submitted
2 Sep 2005
Last updated
1 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 22101745

  • 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.

    PubMed 21060282

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pramipexole and levodopa in combination with benserazide in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 6 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of periodic limb movements while in bed (PLM-I) (time frame: after 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00144209, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.

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