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.)
NCT ID: NCT00152958
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
224 participants
INTERVENTIONAL
2004-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pramipexole
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Charité Campus Virchow-Klinikum
Berlin, , Germany
emovis GmbH
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Chemnitz, , Germany
ClinPharm Internat. GmbH & Co. KG
Görlitz, , Germany
Clinpharm International GmbH & Co. KG
Hellersdorf, , 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
248.546
Identifier Type: -
Identifier Source: org_study_id