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

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ClinicalTrials.gov Identifier: NCT00144209
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date November 1, 2013
Study Start Date  ICMJE February 2003
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
Frequency of periodic limb movements while in bed (PLM-I) [ Time Frame: after 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
The primary endpoint will be the frequency of periodic limb movements while in bed (PLM-Index), as assessed over 3 consecutive nights at the end of the two treatment periods by actigraphy performed on two legs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
  • Changes in RLS-score [ Time Frame: after 4 weeks ]
  • Changes in sleep quality as assessed in a sleep diary [ Time Frame: after 4 weeks ]
  • Changes in Quality of Life (SF-36) [ Time Frame: after 4 weeks ]
  • Mood changes measured by Hospital Anxiety and Depression Scale (HAD) [ Time Frame: after 4 weeks ]
  • Overall impression assessed by Clinical Global Impression (CGI) [ Time Frame: after 4 weeks ]
  • Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: after 4 weeks ]
  • Incidence and Intensity of Adverse events [ Time Frame: up to 10 weeks ]
  • Changes in safety laboratory values [ Time Frame: up to 10 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
Efficacy: - Change in RLS-score - Sleep quality - Change in SF-36 scale, Hospital Anxiety and Depression Scale (HAD), Clinical Global Impression (CGI), Epworth Sleepiness Scale Safety: - AEs, Potential adverse drug reactions - Domperidon needs - Lab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Restless Legs Syndrome
Intervention  ICMJE
  • Drug: pramipexole
  • Drug: levodopa in combination with benserazide
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
58
Original Enrollment  ICMJE
 (submitted: September 2, 2005)
40
Study Completion Date  ICMJE February 2005
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00144209
Other Study ID Numbers  ICMJE 248.518
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Schweiz GmbH.
PRS Account Boehringer Ingelheim
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP