EUCTR2006-006431-42-SK进行中（未招募）1 期
A phase IV randomised, double-blind, placebo-controlled, dose titration trial with pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/day per os to investigate the long-term efficacy, safety and tolerability in patients with idiopathic moderate to severe Restless Legs Syndrome for 26 weeks
Boehringer Ingelheim Pharma Ges mbH0 个研究点目标入组 430 人开始时间: 2007年3月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments
- •2.Male or female out-patients aged 18-85 years
- •3.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:
- •An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs)
- •The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
- •The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
- •The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
- •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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner’s surgical sterilization
- •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)
- •7.All treatment less than 14 days before baseline (Visit 2) or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms, e.g. dopaminergic (other than levodopa and dopamine agonists) or antidopaminergic drugs, non-selective MAO inhibitors, hypnotics, any benzodiazepines, antiepileptics, opioids, ferrous salts.
- •8.Withdrawal symptoms of any medication present at baseline (Visit 2)
- •9.Patients receiving antidepressants with any known changes and instabilities in this medication during the last 4 weeks before baseline (Visit 2). (Patients receiving antidepressants for any indication can only be included in the trial if dose and type of antidepressant medication has been unchanged and stable for at least 4 weeks before baseline and is planned to stay unchanged and stable throughout the trial.)
- •10.History of (during the last 2 years before baseline)/ or presence of a major depressive or bipolar disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any therapy
- •11.History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator’s opinion
- •12. Clinically significant renal disease or calculated creatinine clearance (CrCl) lower than 30 mL/minute at screening (calculation according to the formula of Cockcroft&Gault [R96-0690] see 5.2 laboratory tests)
- •13. Serum ferritin = 30 ng/mL at screening
- •14. Patients with any other clinically significant abnormalities in laboratory parameters at screening at the investigator’s discretion
- •15. Presence of a clinically relevant sleep disorder other than RLS-related
- •16. Diagnosis of diabetic polyneuropathy
- •17. Diagnosis of Parkinson’s disease or syndrome
- •18.History of/or presence of malignant melanoma
- •19.History of/or presence of a clinically relevant ophthalmopathy other than ametropia or presbyopia (e.g. glaucoma, macula degeneration, retinopathy)
- •20.History of/or presence of alcohol abuse or drug addiction within the last 2 years before screening
- •21.Patients with any clinically significant conditions that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health hazard for the patient according to SPC [R06-2803, R06-2767] and/or in the opinion of the investigator
- •22.Patients on a shift-work-schedule who are unable to follow a regular sleep-wake cycle enabling use of study med
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