A comparison of intravenous iron and placebo (NaCl) for treatment of Restless Legs Syndrome (RLS)

Completed

• Conditions: Restless legs syndrome; Nervous System Diseases

• Registration Number: ISRCTN82469428
• Lead Sponsor: Renapharma AB (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International RLS Study Group Rating Scale at 11 weeks

Secondary Outcome Measures

Name	Time	Method
1. Epworth Sleepiness Scale at baseline, after 3 , 7 and 11 weeks, 5 , 8 and 12 months<br>2. Incidences and severities of adverse events, assessed after 3 , 7 and 11 weeks, 5, 8 and 12 months<br>3. To assess the ability of the treatments to correct aberrant haematology and iron status at baseline, after 3 , 7 and 11 weeks, 5 , 8 and 12 months