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.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00152958
First received: September 8, 2005
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- 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:
- 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152958
Locations
| Germany | |
| 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 | |
| Paracelsus-Elena-Klinik | |
| 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
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00152958 History of Changes |
| Other Study ID Numbers: | 248.546 |
| Study First Received: | September 8, 2005 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Psychomotor Agitation Stress, Psychological Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms |
Behavioral Symptoms Pramipexol Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013