A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
Restless Legs Syndrome
About this trial
This is an interventional treatment trial for Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria: Male or female out-patients aged 18-80 Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group RLSRS score > 15 RLS symptoms present at least 2 to 3 days per week within the last 3 months Written informed consent Exclusion Criteria: Women of childbearing potential without adequate contraception, or breastfeeding Concomitant or previous pharmacologically therapy of RLS Clinically significant renal disease, and/or hepatic disease Any of the following lab results at screening: Hb, TSH, T3 or T4, clinically significantly out of normal range, positive urine drug screen Other clinically significant metabolic-endocrine (including diabetes mellitus requiring insulin therapy), haematological, gastro-intestinal disease or pulmonary disease . Poorly controlled cardiovascular disease History or clinical signs of peripheral neuropathy (PNP), myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms, history of or clinical signs for any form of epilepsy or seizures Presence of any sleep disorder History of schizophrenia or any psychotic disorder, history of mental disorders, alcohol abuse or drug addiction History of or clinical signs of malign neoplasm Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated Allergic to pramipexole or its excipients
Sites / Locations
- Clinpharm International GmbH & Co. KG
- Boehringer Ingelheim Investigational Site
- Charité Campus Virchow-Klinikum
- emovis GmbH
- Boehringer Ingelheim Investigational Site
- ClinPharm Internat. GmbH & Co. KG
- Paracelsus-Elena-Klinik
- ClinPharm International GmbH & Co. KG
- Neurologische Klinik der Otto-von-Guericke-Universität
- Universitätsklinikum Giessen und Marburg
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site