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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00275457 |
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome |
Drug: pramipexole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo Controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol ) Orally to Investigate the Safety and Efficacy in Out-Patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-Label or Dou-Ble-Blind Treatment Period |
Estimated Enrollment: | 300 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | April 2004 |
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension
Study Hypotheses:
Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment.
Comparison(s):
Pramipexole vs. Placebo
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group. All of the four criteria must be present:
Exclusion criteria:
Concomitant or previous pharmacologically therapy of RLS as follows:
Any of the following lab results at screening:
Austria | |
Wilhelminenspital der Stadt Wien | |
Wien, Austria, 1160 | |
Sonderkrankenanstalt für neurologischen und | |
Wien, Austria, 1130 | |
Univ.-Klinik für Neurologie | |
Graz, Austria, 8036 | |
AKH der Stadt Linz | |
Linz, Austria, 4021 | |
AKH Universitätsklinik für Psychiatrie | |
Wien, Austria, 1090 | |
Confraternität Privatklinik | |
Wien, Austria, 1080 | |
Univ.-Klinik für Neurologie | |
Innsbruck, Austria, 6020 | |
Germany | |
Boehringer Ingelheim Investigational Site | |
Bad Krozingen, Germany, 79189 | |
Facharzt für Neurologie | |
Emmendingen, Germany, 79312 | |
Boehringer Ingelheim Investigational Site | |
Bad Dürrheim-Sunthausen, Germany, 78073 | |
Universitätsklinikum Giessen und Marburg | |
Marburg, Germany, 35039 | |
emovis GmbH | |
Berlin, Germany, 10629 | |
Boehringer Ingelheim Investigational Site | |
Kehl, Germany, 77694 | |
Boehringer Ingelheim Investigational Site | |
Berlin, Germany, 10625 | |
ClinPharm International GmbH & Co. KG | |
Leipzig, Germany, 04229 | |
Netherlands | |
Boehringer Ingelheim Investigational Site | |
Lichtenvoorde, Netherlands, 7131 CM | |
Boehringer Ingelheim Investigational Site | |
DEURNE, Netherlands, 5751 XJ | |
Boehringer Ingelheim Investigational Site | |
ROELOFARENDSVEEN, Netherlands, 2371 RB | |
Boehringer Ingelheim Investigational Site | |
Beek en Donk, Netherlands, 5741 AR | |
Boehringer Ingelheim Investigational Site | |
Rijswijk, Netherlands, 2281 AK | |
Boehringer Ingelheim Investigational Site | |
Rotterdam, Netherlands, 3082 DC | |
Boehringer Ingelheim Investigational Site | |
Ewijk, Netherlands, 6644 CL | |
Boehringer Ingelheim Investigational Site | |
Den Haag, Netherlands, 2585 LJ | |
Norway | |
Boehringer Ingelheim Investigational Site | |
OSLO, Norway, N-0159 | |
Boehringer Ingelheim Investigational Site | |
TØNSBERG, Norway, N-3111 | |
Boehringer Ingelheim Investigational Site | |
HAMAR, Norway, N-2317 | |
Boehringer Ingelheim Investigational Site | |
OSLO, Norway, N-0303 | |
Sweden | |
Boehringer Ingelheim Investigational Site | |
Örebro, Sweden, 701 85 | |
Läkarhuset Vällingby | |
Vällingby, Sweden, 162 68 | |
Stockholms Neuro Center | |
Stockholm, Sweden, 112 81 | |
Boehringer Ingelheim Investigational Site | |
Uppsala, Sweden, 751 85 | |
Boehringer Ingelheim Investigational Site | |
Göteborg, Sweden, 413 45 | |
Boehringer Ingelheim Investigational Site | |
Västra Frölunda, Sweden, 421 30 | |
Neurologkliniken | |
Stockholm, Sweden, 141 86 |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. Pharma GmbH & Co. KG |
Study ID Numbers: | 248.520 |
Study First Received: | January 11, 2006 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00275457 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women; Netherlands: Medical Ethics Review Committee (METC); Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency |
Neurotransmitter Agents Antioxidants Sleep Disorders Dyssomnias Psychomotor Agitation Dopamine Agonists Dyskinesias Pramipexol |
Sleep Disorders, Intrinsic Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Dopamine Agents Neurobehavioral Manifestations |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Sleep Disorders Antiparkinson Agents Psychomotor Agitation Dopamine Agonists Pramipexol Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Mental Disorders Therapeutic Uses |
Syndrome Restless Legs Syndrome Psychomotor Disorders Neurobehavioral Manifestations Disease Parasomnias Nervous System Diseases Dyssomnias Dyskinesias Protective Agents Pharmacologic Actions Neurologic Manifestations Dopamine Agents Central Nervous System Agents |