A comparison of intravenous iron and placebo (NaCl) for treatment of Restless Legs Syndrome (RLS)
| ISRCTN | ISRCTN82469428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82469428 |
| Secondary identifying numbers | RPV-0105 |
- 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
Scientific
Medical Department
Avesta Hospital
Avesta
SE-774 82
Sweden
Study information
| Study design | Randomised, double-blind, placebo-controlled study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | iron sucrose |
| Primary outcome measure | 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 study start date | 26/06/2003 |
| Completion date | 22/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 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
SE-774 82
Sweden
Sponsor information
Renapharma AB (Sweden)
Industry
Industry
Box 938
Uppsala
SE-751 09
Sweden
| Website | http://www.renapharma.se |
|---|---|
"ROR" |
https://ror.org/03x49ea82 |
Funders
Funder type
Industry
Renapharma AB (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
