A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
NCT ID: NCT00349531
Last Updated: 2012-05-21
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
PHASE4
369 participants
INTERVENTIONAL
2006-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
NCT00472199
Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)
NCT00654498
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
NCT00375284
Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
NCT00275457
Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
NCT00133198
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.
PARALLEL
TREATMENT
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
2. Male or female out-patients aged 18-80 years.
3. Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG \[P03-03355\]. All four criteria must be present to fulfil the diagnosis of RLS:
* An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs)
* The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
* The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
* The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2).
5. IRLS total score \>15 at baseline (Visit 2).
Exclusion Criteria
2. Women of child-bearing potential not having negative pregnancy test at screening.
3. Breastfeeding women.
4. Concomitant or previous pharmacologic therapy for RLS with: dopamine agonists or levodopa (within 14 days prior to baseline), levodopa with augmentation, unsuccessful prior treatment with non-ergot dopamine agonists.
5. All treatment less than 14 days or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms.
6. Withdrawal symptoms.
7. Pramipexole non-responders in other indications than RLS.
8. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
9. Diabetes mellitus requiring insulin therapy.
10. Any of the following laboratory results at screening:
* any clinically significant abnormalities in laboratory parameters;
* haemoglobin below LLN.
11. Clinically significant renal disease or calculated creatinine clearance lower than 30 mL/minute.
12. Clinically significant hepatic disease or GPT \>2 times the ULN.
13. Serum ferritin \<10 ng/mL.
14. History of/or malignant melanoma.
15. History of/or clinically significant vision abnormalities.
16. History of/or any other sleep disorder (other than RLS-related).
17. History of/or major depressive disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any medical therapy.
18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigator's opinion.
19. History of/or alcohol abuse or drug addiction (within 2 years).
20. Patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.
21. Participation in an investigational drug study within one month.
22. Any clinically significant conditions that would interfere or constitute a health hazard for the patient.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Boehringer Ingelheim
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
248.615.45103 Boehringer Ingelheim Investigational Site
Kongens Lyngby, , Denmark
248.615.45102 Boehringer Ingelheim Investigational Site
København K, , Denmark
248.615.45101 Boehringer Ingelheim Investigational Site
København NV, , Denmark
248.615.45104 Boehringer Ingelheim Investigational Site
Vaerløse, , Denmark
248.615.35101 Boehringer Ingelheim Investigational Site
Espoo, , Finland
248.615.35104 Boehringer Ingelheim Investigational Site
Joensuu, , Finland
248.615.35103 Boehringer Ingelheim Investigational Site
Lahti, , Finland
248.615.35102 Boehringer Ingelheim Investigational Site
Oulu, , Finland
248.615.49109 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.615.49105 Boehringer Ingelheim Investigational Site
Görlitz, , Germany
248.615.49108 Boehringer Ingelheim Investigational Site
Hattingen, , Germany
248.615.49106 Boehringer Ingelheim Investigational Site
München, , Germany
248.615.49102 Boehringer Ingelheim Investigational Site
Schwerin, , Germany
248.615.49103 Boehringer Ingelheim Investigational Site
Steglitz, , Germany
248.615.49101 Boehringer Ingelheim Investigational Site
Ulm, , Germany
248.615.49107 Boehringer Ingelheim Investigational Site
Witten, , Germany
248.615.49104 Boehringer Ingelheim Investigational Site
Würzburg, , Germany
248.615.35302
Birr, , Ireland
248.615.35301 Boehringer Ingelheim Investigational Site
Carrigtohill, , Ireland
248.615.35303
Castlecomer, , Ireland
248.615.39007 Policlinico di Bari - Università di Bari
Bari, , Italy
248.615.39006 Ospedale Civile di Dolo
Dolo (VE), , Italy
248.615.39002 Ospedale S. Martino - A. O. Università di Genova
Genova, , Italy
248.615.39008 Policlinico Gaetano Martino
Messina, , Italy
248.615.39001 Istituto San Raffaele Turro
Milan, , Italy
248.615.39004 IRCCS Fondazione Istituto Neurologico "C. Mondino"
Pavia, , Italy
248.615.39005 Ospedale S. Chiara
Pisa, , Italy
248.615.39003 A. O. Santa Maria della Misericordia
Udine, , Italy
248.615.47101 Boehringer Ingelheim Investigational Site
Bekkestua, , Norway
248.615.47102 Boehringer Ingelheim Investigational Site
Fevik, , Norway
248.615.47104 Boehringer Ingelheim Investigational Site
Moelv, , Norway
248.615.47103 Boehringer Ingelheim Investigational Site
Oslo, , Norway
248.615.47105 Boehringer Ingelheim Investigational Site
Tvedestrand, , Norway
248.615.3408 Hospital Nuestra Señora de Sonsoles
Ávila, , Spain
248.615.3402
Maderid, , Spain
248.615.3404 Hospital General Universitario Gregorio Marañón
Madrid, , Spain
248.615.3406
Madrid, , Spain
248.615.3407
Madrid, , Spain
248.615.3403 Hospital General de Catalunya
San Cugat Del Valles (Barcelona), , Spain
248.615.46101 Boehringer Ingelheim Investigational Site
Gothenburg, , Sweden
248.615.46103 Boehringer Ingelheim Investigational Site
Gothenburg, , Sweden
248.615.46102 Boehringer Ingelheim Investigational Site
Hedemora, , Sweden
248.615.46104 Boehringer Ingelheim Investigational Site
Örebro, , Sweden
248.615.44006 Boehringer Ingelheim Investigational Site
Buckshaw Village, Chorley, , United Kingdom
248.615.44004 Boehringer Ingelheim Investigational Site
Cambridge, , United Kingdom
248.615.44007 Boehringer Ingelheim Investigational Site
Manchester, , United Kingdom
248.615.44009 Boehringer Ingelheim Investigational Site
Reading, , United Kingdom
248.615.44002 Boehringer Ingelheim Investigational Site
Romford, , United Kingdom
248.615.44005 Boehringer Ingelheim Investigational Site
West Green, Crawley, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hornyak M, Sohr M, Busse M; 604 and 615 Study Groups. Evaluation of painful sensory symptoms in restless legs syndrome: experience from two clinical trials. Sleep Med. 2011 Feb;12(2):186-9. doi: 10.1016/j.sleep.2010.11.007. Epub 2011 Jan 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
248.615
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.