Swiss Restless Legs Syndrome Trial (SRLS) - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00144209

Purpose

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.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: pramipexole Drug: levodopa in combination with benserazide	Phase III

MedlinePlus related topics: Restless Legs

Drug Information available for: Pramipexol Pramipexole dihydrochloride Levodopa Benserazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Swiss Pramipexole in Restless Legs Syndrome Trial

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Estimated Study Completion Date:	February 2005
Estimated Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	25 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144209

Locations

Switzerland
Boehringer Ingelheim Investigational Site
Zurich, Switzerland, 8091
Boehringer Ingelheim Investigational Site
Bern, Switzerland, 3000
Boehringer Ingelheim Investigational Site
Lugano, Switzerland, CH-6900
Boehringer Ingelheim Investigational Site
Basel, Switzerland, 4025
Boehringer Ingelheim Investigational Site
Zurzach, Switzerland, 5330
Boehringer Ingelheim Investigational Site
Basel, Switzerland, 4031

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. Schweiz GmbH.

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	248.518
Study First Received:	September 2, 2005
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00144209
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Levodopa
Ekbom syndrome
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dyskinesias
Pramipexol
Sleep Disorders, Intrinsic

Signs and Symptoms
Dopamine
Mental Disorders
Restless Legs Syndrome
Benserazide
Neurologic Manifestations
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents
Antioxidants
Disease
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Parasomnias
Antiparkinson Agents
Enzyme Inhibitors

Dopamine Agonists
Protective Agents
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Psychomotor Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009