A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

Exclusion Criteria

• •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 partners surgical sterilization.
• •2. Any women of child-bearing potential not having negative pregnancy test at screening.
• •3. Breastfeeding women.
• •4. Concomitant or previous pharmacologic therapy for RLS as follows:
• •* Any intake of dopamine agonists within 14 days prior to baseline (Visit 2).
• •* Any intake of L-dopa within 14 days prior to baseline (Visit 2).
• •* Any intake of L-dopa prior to baseline visit, if augmentation in RLS symptoms was observed.
• •* Unsuccessful prior treatment with non-ergot dopamine agonists (e.g., pramipexole, ropinirole).
• •5. 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, sympathomimetics, neuroleptics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, ferrous salts, magnesium, folic acid, vitamin B12, antihistaminics, lithium, metoclopramide.
• •6. Withdrawal symptoms of any medication must not be present at baseline (Visit 2).
• •7. Previous pramipexole non-responders in other indications than RLS.
• •8. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
• •9. Confirmed diagnosis of diabetes mellitus requiring insulin therapy.
• •10. Any of the following lab results at screening:
• •* Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigators discretion.
• •* Haemoglobin (Hb) below lower limit of normal (LLN).