Swiss Restless Legs Syndrome Trial (SRLS)
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00144209
First received: September 2, 2005
Last updated: May 18, 2012
Last verified: May 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Swiss Pramipexole in Restless Legs Syndrome Trial |
Resource links provided by NLM:
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 |
| 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 | |
| Basel, Switzerland, 4025 | |
| Boehringer Ingelheim Investigational Site | |
| Basel, Switzerland, 4031 | |
| Boehringer Ingelheim Investigational Site | |
| Bern, Switzerland, 3000 | |
| Boehringer Ingelheim Investigational Site | |
| Lugano, Switzerland, CH-6900 | |
| Boehringer Ingelheim Investigational Site | |
| Zurich, Switzerland, 8091 | |
| Boehringer Ingelheim Investigational Site | |
| Zurzach, Switzerland, 5330 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Schweiz GmbH. |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00144209 History of Changes |
| Other Study ID Numbers: | 248.518 |
| Study First Received: | September 2, 2005 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Benserazide Levodopa |
Pramipexol Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Antioxidants Protective Agents Dopamine Agonists |
ClinicalTrials.gov processed this record on May 16, 2013