Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPV-0105
Study information
Scientific title
A randomised, double-blind, comparative, multi-centre study of intravenous iron and placebo (NaCl) for treatment of Restless Legs Syndrome (RLS)
Acronym
Study hypothesis
Is 5 x 200 mg iron sucrose over 3 weeks more effective in the treatment of restless legs than placebo?
Ethics approval
University Hospital, Uppsala. Date of approval: 13 June 2003 (ref: 03-141)
Study design
Randomised, double-blind, placebo-controlled study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Restless legs syndrome
Intervention
200 mg iron sucrose intravenously 5 times over 3 weeks versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
iron sucrose
Primary outcome measures
International RLS Study Group Rating Scale at 11 weeks
Secondary outcome measures
1. Epworth Sleepiness Scale at baseline, after 3 , 7 and 11 weeks, 5 , 8 and 12 months
2. Incidences and severities of adverse events, assessed after 3 , 7 and 11 weeks, 5, 8 and 12 months
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
Overall trial start date
26/06/2003
Overall trial end date
22/06/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
26/06/2003
Recruitment end date
22/06/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Medical Department
Avesta
SE-774 82
Sweden
Sponsor information
Organisation
Renapharma AB (Sweden)
Sponsor details
Box 938
Uppsala
SE-751 09
Sweden
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Renapharma AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary