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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00349531 |
The primary objective of this study is to investigate the effects on RLS symptoms and sleep disturba nce of pramipexole (Mirapexin) 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome
Condition | Intervention | Phase |
---|---|---|
Restless Legs Syndrome |
Drug: Pramipexole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV Randomised, Double-Blind, Placebo-Controlled, Dose Titration Trial With Pramipexole (Sifrol?, Mirapexin?) 0.125-0.75 mg/Day Per os for 12 Weeks to Investigate the Effects on RLS Symptoms (IRLS) and Sleep Disturbance (MOS Sleep Scale) in Out-Patients With Idiopathic Restless Legs Syndrome |
Estimated Enrollment: | 320 |
Estimated Study Completion Date: | May 2007 |
The primary objective of this study is to investigate the effects on RLS symptoms (based on IRLS) an d sleep disturbance (based on MOS sleep scale) of pramipexole 0.125 mg/day to 0.75 mg/day per os for 12 weeks, compared to placebo, in the treatment of patients with idiopathic Restless Legs Syndrome (RLS). Secondary objectives are to investigate the effects on clinical global impressions-global improvemen t (based on CGI-I responder rate), RLS (based on IRLS responder rate), other MOS dimensions (based o n MOS sleep scale), daytime symptoms (based on items 4-6 of the RLS-6 scales), associated mood distu rbance (based on item 10 of the IRLS scale), pain in limbs (based on a visual analogue scale), cogni tive function (based on verbal fluency tests), quality of life in RLS (based on Johns Hopkins RLS-Qo L questionnaire), patient global impression (based on PGI responder rate) and safety (based on AE pr ofile) of pramipexole in comparison to placebo. The expected duration of the screening period is 4-28 days, depending on the required wash-out from concomitant medications and each individual patients situation. The duration of the treatment period for individual patients is 12 weeks (+-3 days). The duration of the follow-up period is 7 days (+-3 days). The total duration of patient participation is 14-17 weeks.
Study Hypothesis:
This study has the potential to demonstrate safety and efficacy of pramipexole o n RLS symptoms and on RLS-associated sleep disturbances from which the majority of RLS patients suffer. The study will therefore explore the role and efficacy o f pramipexole in RLS patients with concomitant sleep disturbances and may benefi t nearly all RLS patients.
Comparison(s):
Placebo
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
1.Women of child-bearing potential who do not use during the trial an adequate method of contraception.2.Women of child-bearing potential not having negative pregnancy test at screening.3.Breastfeeding women.4.Concomitant or previous pharmacologic therapy for RLS with: dopamine agonists or levodopa (within 14 days prior to baseline), levodopa with augmentation, unsuccessful prior treatment with non-ergot dopamine agonists.5.All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.6.Withdrawal symptoms.7.Pramipexole non-responders in other indications than RLS.8.Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.9.Diabetes mellitus requiring insulin therapy.10.Any of the following laboratory results at screening: any clinically significant abnormalities in laboratory parameters;haemoglobin below LLN.11.Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.12.Clinically significant hepatic disease or GPT >2 times the ULN.13.Serum ferritin <10 ng/mL.14.History of/or malignant melanoma.15.History of/or clinically significant vision abnormalities.16.History of/or any other sleep disorder (other than RLS-related).17.History of/or major depressive disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any medical therapy.18.History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator?s opinion.19.History of/or alcohol abuse or drug addiction (within 2 years).20.Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.21.Participation in an investigational drug study within one month.22.Any clinically significant conditions that would interfere or constitute a health hazard for the patient.
Study Chair: | Boehringer Ingelheim Study Coordinator | BI Italy |
Study ID Numbers: | 248.615 |
Study First Received: | July 6, 2006 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00349531 |
Health Authority: | Italy: Comitato Etico della Fondazione Centro S. Raffaele del Monte Tabor (IRCCS) di Milano; Ireland: The Irish Medicines Board; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Spain: Agencia Espanola del Medicamento y Productos Sanitarios; Sweden: Medical Products Agency; Great Britain: MHRA |
Ekbom syndrome Sleep Disorders Dyssomnias Psychomotor Agitation Dyskinesias Pramipexol Sleep Disorders, Intrinsic |
Signs and Symptoms Dopamine Mental Disorders Restless Legs Syndrome Neurologic Manifestations Neurobehavioral Manifestations |
Neurotransmitter Agents Disease Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Parasomnias Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Psychomotor Disorders Dopamine Agents Central Nervous System Agents |