Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
NCT ID: NCT00806026
Last Updated: 2021-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
731 participants
INTERVENTIONAL
2008-12-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PBO/PGB 300 mg
placebo and pregabalin
following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.
PBO/PPX 0.25 mg
pramipexol
following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
PBO/PPX 0.5 mg
pramipexol
following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
PGB 300 mg
Pregabalin
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
PPX 0.25 mg
pramipexol
pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
PPX 0.5 mg
pramipexol
pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
Interventions
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placebo and pregabalin
following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.
pramipexol
following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
pramipexol
following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.
Pregabalin
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
pramipexol
pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
pramipexol
pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* RLS symptoms occur predominantly in the evening
* RLS history at least 6 months
* IRLS =\> 15 at the beginning and the end of placebo run-in
* Have =\>15 nights with RLS symptoms in the month prior to screening
Exclusion Criteria
* Current augmentation due to RLS treatment
* Placebo responders identified during the placebo run-in
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
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Jasper, Alabama, United States
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Tuscaloosa, Alabama, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Northridge, California, United States
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Redondo Beach, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Boca Raton, Florida, United States
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Hallandale, Florida, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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South Miami, Florida, United States
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Atlanta, Georgia, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Chevy Chase, Maryland, United States
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Newton, Massachusetts, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Princeton, New Jersey, United States
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New York, New York, United States
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Salisbury, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Lafayette Hill, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Walla Walla, Washington, United States
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Helsinki, , Finland
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Kuopio, , Finland
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Tampere, , Finland
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Turku, , Finland
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Achim, , Germany
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Bad Saarow, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Bremen, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Freiburg im Breisgau, , Germany
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Gelsenkirchen, , Germany
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Halle, , Germany
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Hamm, , Germany
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Jena, , Germany
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Jülich, , Germany
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Kassel, , Germany
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Kassel, , Germany
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Köthen, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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München, , Germany
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Oldenburg, , Germany
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Prien am Chiemsee, , Germany
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Schwerin, , Germany
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Siegen, , Germany
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Ulm, , Germany
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Ulm, , Germany
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Unterhaching, , Germany
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Westerstede, , Germany
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Würzburg, , Germany
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Pavia, , Italy
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Pisa, , Italy
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Rome, , Italy
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Rome, , Italy
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Troina, , Italy
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Troina(EN), , Italy
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Ede, , Netherlands
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Zwolle, , Netherlands
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Barcelona, Cataluña/Spain, Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Avesta, , Sweden
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Avesta, , Sweden
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Örebro, , Sweden
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Örebro, , Sweden
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Skövde, , Sweden
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Skövde, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Reading Berks, , United Kingdom
Countries
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References
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Allen RP, Chen C, Garcia-Borreguero D, Polo O, DuBrava S, Miceli J, Knapp L, Winkelman JW. Comparison of pregabalin with pramipexole for restless legs syndrome. N Engl J Med. 2014 Feb 13;370(7):621-31. doi: 10.1056/NEJMoa1303646.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081186
Identifier Type: -
Identifier Source: org_study_id
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