The primary objective is to assess sustained efficacy in patients who have responded to a 6 month treatment with open-label pramipexole.

Secondary objectives are the measurement of severity of the RLS, assessment of early withdrawal phenomena after termination of trial medication, augmentation under treatment, sleepiness, quality of life and subjective wellbeing, the physician’s clinical assessment of symptom severity and improvement. Another secondary objective is safety and tolerability of treatment.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: Pramipexole	Phase III

Further Study Details: 

Primary Outcomes: The primary endpoint was the time to target event after randomisation. According to Kaplan-Meier survival analysis and log-rank test, the time to target event was significantly shorter in the placebo group than in the pramipexole group (p<0.0001).
Secondary Outcomes: The treatment group difference was highly significant for the mean changes from baseline of RLSRS total score(p<0.0001) and for the CGI-I responders (p<0.0001).
Expected Total Enrollment:  224

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Germany
      emovis GmbH, Berlin,  10629,  Germany
      Boehringer Ingelheim Investigational Site, Berlin,  10625,  Germany
      Studienambulanz ClinPharm, Berlin,  12627,  Germany
      Fachärztin für Neurologie, Berlin,  10969,  Germany
      Neurologische Klinik der Charité, Berlin,  13353,  Germany
      Neurologe, München,  80331,  Germany
      Arzt für Neurologie, Würzburg,  97070,  Germany
      Paracelsus-Elena-Klinik, Kassel,  34128,  Germany
      Philipps-Universität Marburg, Marburg,  35039,  Germany
      Neurologische Klinik der Otto-von-Guericke-Universität, Magdeburg,  39120,  Germany
      ClinPharm International GmbH & Co. KG, Leipzig,  04229,  Germany
      Studienambulanz ClinPharm, Görlitz,  02826,  Germany
      Pharmakologisches Studienzentrum Chemnitz, Chemnitz,  09111,  Germany

Study chairs or principal investigators

Sophie Banzet, Dr.,  Study Chair,  Boehringer Ingelheim Pharmaceuticals   

Study ID Numbers:  248.546
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152958
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13