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

ISRCTN	ISRCTN82469428
DOI	https://doi.org/10.1186/ISRCTN82469428
Protocol serial number	RPV-0105
Sponsor	Renapharma AB (Sweden)
Funder	Renapharma AB (Sweden)

Submission date: 11/02/2008
Registration date: 15/02/2008
Last edited: 28/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jan Ulfberg
Scientific

Medical Department
Avesta Hospital
Avesta
SE-774 82
Sweden

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled study.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised, double-blind, comparative, multi-centre study of intravenous iron and placebo (NaCl) for treatment of Restless Legs Syndrome (RLS)
Study objectives	Is 5 x 200 mg iron sucrose over 3 weeks more effective in the treatment of restless legs than placebo?
Ethics approval(s)	University Hospital, Uppsala. Date of approval: 13 June 2003 (ref: 03-141)
Health condition(s) or problem(s) studied	Restless legs syndrome
Intervention	200 mg iron sucrose intravenously 5 times over 3 weeks versus placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	iron sucrose
Primary outcome measure(s)	International RLS Study Group Rating Scale at 11 weeks
Key secondary outcome measure(s)	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
Completion date	22/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	26/06/2003
Date of final enrolment	22/06/2005

Locations

Countries of recruitment

Sweden

Study participating centre

Medical Department

Avesta
SE-774 82
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes