Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
NCT ID: NCT00356096
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
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COMPLETED
PHASE4
404 participants
INTERVENTIONAL
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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pramipexole
Eligibility Criteria
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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. In addition all of the following must be demonstrated at Visit 2 (baseline):
IRLS total score \>15 A score of \>=2 for item 10 of the IRLS rating scale
Exclusion Criteria
2. Any women of child-bearing potential not having negative pregnancy test at screening
3. Breastfeeding women
4. Concomitant or previous pharmacologic therapy for RLS
5. All treatment less than 14 days before baseline or concomitant treatment with medication or dietary supplements, which could significantly influence RLS symptoms
6. Withdrawal symptoms of any medication must not be present at baseline
7. Previous pramipexole non-responders in other indications than RLS.
8. Hypersensitivity to pramipexole or any other component of the investigational product
9. Diagnosis of diabetes mellitus requiring insulin
10. Any of the following laboratory results at screening: clinically significant abnormalities at the investigatos discretion; Hb below lower limit of normal
11. Clinically significant renal disease at screening
12. Clinically significant hepatic disease at screening
13. Serum ferritin \<10 ng/mL at screening.
14. History of/or malignant melanoma.
15. History of/or clinically significant vision abnormalities
16. History of/or any other sleep disorder
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, or BDI-II total score \>28
18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigators opinion
19. History of/or alcohol abuse or drug addiction within the last 2 years before screening
20. Patients on a shift-work-schedule or otherwise unable to follow a regular sleep-wake cycle
21. Participation in an investigational drug study within one month prior to the start of this study
22. Patients with any clinically significant conditions that in the opinion of the investigator
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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248.604.35801 Boehringer Ingelheim Investigational Site
Espoo, , Finland
248.604.35805 Boehringer Ingelheim Investigational Site
Helsinki, , Finland
248.604.35803 Boehringer Ingelheim Investigational Site
Lahti, , Finland
248.604.35802 Boehringer Ingelheim Investigational Site
Oulu, , Finland
248.604.3301A HOP Le Vinatier,Psychiat,Bron
Bron, , France
248.604.3304B Hôpital Roger Salengro
Lille, , France
248.604.3307A Cabinet Médical
Montbrison, , France
248.604.3303A Hôpital Gui de Chauliac
Montpellier Cédex 5, , France
248.604.3303C Hôpital Gui de Chauliac
Montpellier Cédex 5, , France
248.604.3302A Hôpital Pitié Salpétrière
Paris Cédex 13, , France
248.604.3305B Hôpital du Haut Levêque
Pessac Cédex, , France
248.604.4902 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.604.4904 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.604.4905 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.604.4906 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.604.4909 Boehringer Ingelheim Investigational Site
Chemnitz, , Germany
248.604.4901 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau, , Germany
248.604.4903 Boehringer Ingelheim Investigational Site
Hellersdorf, , Germany
248.604.4907 Boehringer Ingelheim Investigational Site
Kassel, , Germany
248.604.4910 Boehringer Ingelheim Investigational Site
Leipzig, , Germany
248.604.4908 Boehringer Ingelheim Investigational Site
Marburg, , Germany
248.604.4911 Boehringer Ingelheim Investigational Site
München, , Germany
248.604.35305
Carrigtohill, , Ireland
248.604.35302 Boehringer Ingelheim Investigational Site
Castledermot, , Ireland
248.604.3901 Università degli Studi di Bologna
Bologna, , Italy
248.604.3905 Casa di Cura Villa Serena
Città S. Angelo (PE), , Italy
248.604.3906 Clinica Psichiatrica
Pisa, , Italy
248.604.3902 IRCCS San Raffaele
Roma, , Italy
248.604.3909 IRCCS Fondazione "Salvatore Maugeri"
Telese Terme (be), , Italy
248.604.3908 Azienda Sanitaria San Giovanni Battista
Torino, , Italy
248.604.3904 IRCCS Oasi Maria SS
Troina (Enna), , Italy
248.604.82001 Boehringer Ingelheim Investigational Site
Daegu, , South Korea
248.604.82003 Boehringer Ingelheim Investigational Site
Incheon, , South Korea
248.604.82002 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
248.604.82004 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
248.604.3401
Madrid, , Spain
248.604.3403
Madrid, , Spain
248.604.3405
Madrid, , Spain
248.604.3407
Oviedo, , Spain
248.604.3402
San Cugat Del Vallés (Barcelona), , Spain
248.604.3404 Hospital de Donostia
San Sebastián, , Spain
248.604.4602 Boehringer Ingelheim Investigational Site
Gothenburg, , Sweden
248.604.4603 Boehringer Ingelheim Investigational Site
Gothenburg, , Sweden
248.604.4601 Boehringer Ingelheim Investigational Site
Hedemora, , Sweden
248.604.4605 Boehringer Ingelheim Investigational Site
Örebro, , Sweden
248.604.4604 Boehringer Ingelheim Investigational Site
Skövde, , Sweden
248.604.4606 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
248.604.44004 Boehringer Ingelheim Investigational Site
Cambridge, , United Kingdom
248.604.44006 Boehringer Ingelheim Investigational Site
Chorley, , United Kingdom
248.604.44001 Boehringer Ingelheim Investigational Site
London, , United Kingdom
248.604.44007 Boehringer Ingelheim Investigational Site
Manchester, , United Kingdom
248.604.44009 Boehringer Ingelheim Investigational Site
Reading, , United Kingdom
248.604.44002 Boehringer Ingelheim Investigational Site
Romford, , United Kingdom
248.604.44005 Boehringer Ingelheim Investigational Site
West Green, Crawley, , United Kingdom
Countries
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References
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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
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248.604
Identifier Type: -
Identifier Source: org_study_id
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