A randomised, double-blind, comparative, multi-centre study of intravenous iron and placebo (NaCl) for treatment of Restless Legs Syndrome (RLS)

Renapharma AB (Sweden)0 个研究点目标入组 60 人开始时间: 2008年2月15日最近更新: 2015年1月13日

研究概览

暂无简介。

•1. Aged 18-70 years
•2. RLS defined by four cardinal criteria
•3. Ten points or more on the International RLS (IRLS) Study Group Rating Scale
•4. S-ferritin below 45 µg/L, and with folic acid and vitamin B12 within reference values
•5. Signed informed consent

•1. Treatment with any of the following:
•1.1. Psychopharmacological treatment with antidepressive and dopaminergic agents, sedatives, anticonvulsants and/or pain relievers, i.e. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or stronger, during the preceding 2 weeks. This was changed in study protocol clarification number 2 to ...i.e. with the exception of NSAIDs - during the last 2 weeks.
•1.2. Calcium antagonists, antihistaminic or antiemetic drugs during the preceding 2 weeks.
•1.3. Iron administration during the preceding 2 months
•1.4. Nutritional supplements or natural pharmaceuticals containing iron
•1.5. Antiepileptics
•1.6. Vitamin B12 or folic acid
•2. Presence of clinically significant disease/dysfunction, which in the opinion of the investigator should disqualify the patient from this study, such as asymptomatic intestinal bleeding
•3. Patients suffering from obstructive sleep apnoea syndrome
•4. S-creatinine >130 µmol/L
•5. Positive result of pregnancy test
•6. Breast-feeding women
•7. Contraindications for iron sucrose

发起方

Renapharma AB (Sweden)