Condition category
Nervous System Diseases
Date applied
11/02/2008
Date assigned
15/02/2008
Last edited
28/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jan Ulfberg

ORCID ID

Contact details

Medical Department
Avesta Hospital
Avesta
SE-774 82
Sweden

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

http://www.renapharma.se

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

Publication citations

Additional files

Editorial Notes