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.)

This study has been completed.

First Received on September 8, 2005.  
Last Updated on May 18, 2012  
History of Changes
This Clinical Trial Sponsored By: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00152958

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
Restless Legs Syndrome Drug: Pramipexole Phase 3

Study Type: Study Interventional
Study Design: Allocation: Randomized
Study Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomised Withdrawal Study of 3 Month Duration 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.)

Resource links provided by NLM:

MedlinePlus related topics:
Restless Legs
Drug Information available for:
Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures For Clinical Trial:

  • 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 Outcome Measures For Clinical Trial:

  • 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).

Estimated Enrollment: 224
Study Start Date: January 2004
Estimated Study Completion Date: May 2005

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152958

emovis GmbH
Berlin, Germany
Boehringer Ingelheim Investigational Site
Berlin, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Clinpharm International GmbH & Co. KG
Berlin (Hellersdorf), Germany
Boehringer Ingelheim Investigational Site
Chemnitz, Germany
ClinPharm Internat. GmbH & Co. KG
Görlitz, Germany
Kassel, Germany
ClinPharm International GmbH & Co. KG
Leipzig, Germany
Neurologische Klinik der Otto-von-Guericke-Universität
Magdeburg, Germany
Universitätsklinikum Giessen und Marburg
Marburg, Germany
Boehringer Ingelheim Investigational Site
München, Germany
Boehringer Ingelheim Investigational Site
Würzburg, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:

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