Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
NCT ID: NCT00472199
Last Updated: 2014-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
331 participants
INTERVENTIONAL
2007-05-31
Brief Summary
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The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pramipexole
4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks.
Pramipexole
Placebo
4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks.
Placebo
Interventions
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Pramipexole
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Male or female out-patients aged 18-85 years
3. Diagnosis of idiopathic RLS according to the clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG) \[P03-03355\]. All four criteria must be present to fulfil the diagnosis of RLS.
4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2)
5. IRLS total score \>15 at baseline (Visit 2)
Exclusion Criteria
2. Any woman of child-bearing potential not having a negative pregnancy test at screening
3. Breastfeeding women
4. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
5. Diagnosis of augmentation under previous pharmacological RLS treatment
6. Concomitant or previous pharmacologic therapy as follows: Any intake of dopamine agonists within 14 days prior to baseline (Visit 2); Any intake of levodopa within 14 days prior to baseline (Visit 2); Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole);
18 Years
85 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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248.629.4302 Boehringer Ingelheim Investigational Site
Innsbruck, , Austria
248.629.4304 Boehringer Ingelheim Investigational Site
Linz, , Austria
248.629.3201 Boehringer Ingelheim Investigational Site
Edegem, , Belgium
248.629.35801 Boehringer Ingelheim Investigational Site
Espoo, , Finland
248.629.35805 Boehringer Ingelheim Investigational Site
Helsinki, , Finland
248.629.35804 Boehringer Ingelheim Investigational Site
Joensuu, , Finland
248.629.35802 Boehringer Ingelheim Investigational Site
Oulu, , Finland
248.629.35806 Boehringer Ingelheim Investigational Site
Tampere, , Finland
248.629.4902 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.629.4908 Boehringer Ingelheim Investigational Site
Bochum, , Germany
248.629.4901 Boehringer Ingelheim Investigational Site
Ellwangen, , Germany
248.629.4904 Boehringer Ingelheim Investigational Site
Hellersdorf, , Germany
248.629.4906 Boehringer Ingelheim Investigational Site
Herborn, , Germany
248.629.4905 Boehringer Ingelheim Investigational Site
Leipzig, , Germany
248.629.4909 Boehringer Ingelheim Investigational Site
Schwerin, , Germany
248.629.4903 Boehringer Ingelheim Investigational Site
Steglitz, , Germany
248.629.4907 Boehringer Ingelheim Investigational Site
Würzburg, , Germany
248.629.35301 Boehringer Ingelheim Investigational Site
Carrigtohill, , Ireland
248.629.35302 Boehringer Ingelheim Investigational Site
Co. Kildare, , Ireland
248.629.35303 Boehringer Ingelheim Investigational Site
Co. Tipperary, , Ireland
248.629.31001 Boehringer Ingelheim Investigational Site
Bennebroek, , Netherlands
248.629.31005 Boehringer Ingelheim Investigational Site
Hoogwoud, , Netherlands
248.629.31006 Boehringer Ingelheim Investigational Site
Musselkanaal, , Netherlands
248.629.31002 Boehringer Ingelheim Investigational Site
Oude Pekela, , Netherlands
248.629.31003 Boehringer Ingelheim Investigational Site
Oude Pekela, , Netherlands
248.629.31004 Boehringer Ingelheim Investigational Site
Rijswijk, , Netherlands
248.629.4204 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
248.629.4205 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
248.629.4202 Boehringer Ingelheim Investigational Site
Brezno, , Slovakia
248.629.4201 Boehringer Ingelheim Investigational Site
Košice, , Slovakia
248.629.4203 Boehringer Ingelheim Investigational Site
Martin, , Slovakia
248.629.3402 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
248.629.3405 Boehringer Ingelheim Investigational Site
Granada, , Spain
248.629.3401 Boehringer Ingelheim Investigational Site
Madrid, , Spain
248.629.3403 Boehringer Ingelheim Investigational Site
San Sebastián, , Spain
248.629.3406 Hospital Arnau de Vilanova
Valencia, , Spain
248.629.44003 Boehringer Ingelheim Investigational Site
Chorley, , United Kingdom
248.629.44006 Boehringer Ingelheim Investigational Site
Edgbaston, Birmingham, , United Kingdom
248.629.44004 Boehringer Ingelheim Investigational Site
Glasgow, , United Kingdom
248.629.44001 Boehringer Ingelheim Investigational Site
Manchester, , United Kingdom
248.629.44002 Boehringer Ingelheim Investigational Site
Reading, , United Kingdom
248.629.44005 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool, , United Kingdom
Countries
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Related Links
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Other Identifiers
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EUDRACT2006-006431-42
Identifier Type: -
Identifier Source: secondary_id
248.629
Identifier Type: -
Identifier Source: org_study_id
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