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

Boehringer Ingelheim Limited0 sites430 target enrollmentMarch 29, 2007

Overview

No summary available.

Registry

who.int

Start Date

March 29, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.