A phase IV randomised, double-blind, placebo-controlled, dose titration trial with pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/day per os to investigate the long-term efficacy, safety and tolerability in patients with idiopathic moderate to severe Restless Legs Syndrome for 26 weeks
- Conditions
- Restless Legs SyndromeMedDRA version: 9.1Level: PTClassification code 10058920Term: Restless legs syndrome
- Registration Number
- EUCTR2006-006431-42-IE
- Lead Sponsor
- Boehringer Ingelheim Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 430
1. Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments
2. Male or female out-patients aged 18-85 years
3. Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
• An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs)
• The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
• The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
• The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2)
5. IRLS total score >15 at baseline (Visit 2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner’s surgical sterilization
2. Any woman of child-bearing potential not having a negative pregnancy test at screening
3. Breastfeeding women
4. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
5. Diagnosis of augmentation under previous pharmacological RLS treatment
6. Concomitant or previous pharmacologic therapy as follows:
• Any intake of dopamine agonists within 14 days prior to baseline (Visit 2)
• Any intake of levodopa within 14 days prior to baseline (Visit 2)
• Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole)
7. All treatment less than 14 days before baseline (Visit 2) or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms, e.g. dopaminergic (other than levodopa and dopamine agonists) or antidopaminergic drugs, non-selective MAO inhibitors, hypnotics, any benzodiazepines, antiepileptics, opioids, ferrous salts.
8. Withdrawal symptoms of any medication present at baseline (Visit 2)
9. Patients receiving antidepressants with any known changes and instabilities in this medication during the last 4 weeks before baseline (Visit 2). (Patients receiving antidepressants for any indication can only be included in the trial if dose and type of antidepressant medication has been unchanged and stable for at least 4 weeks before baseline and is planned to stay unchanged and stable throughout the trial.)
10. History of (during the last 2 years before baseline)/ or presence of a major depressive or bipolar disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any therapy
11. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator’s opinion
12. Clinically significant renal disease or calculated creatinine clearance (CrCl) lower than 30 mL/minute at screening (calculation according to the formula of Cockcroft&Gault [R96-0690] see 5.2 laboratory tests)
13. Serum ferritin = 30 ng/mL at screening
14. Patients with any other clinically significant abnormalities in laboratory parameters at screening at the investigator’s discretion
15. Presence of a clinically relevant sleep disorder other than RLS-related
16. Diagnosis of diabetic polyneuropathy
17. Diagnosis of Parkinson’s disease or syndrome
18. History of/or presence of malignant melanoma
19. History of/or presence of a clinically relevant ophthalmopathy other than ametropia or presbyopia (e.g. glaucoma, macula degeneration, retinopathy)
20. History of/or presence of alcohol abuse or drug addiction within the last 2 years before screening
21. Patients with any clinically significant conditions that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health hazard for the patient according to SPC [R06-2803, R06-2767] and/or in the opinion of the investigator
22. Patients on a shift-work-schedule who are unable to follow a regular sleep-wake cycle enabling use of study med
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method