Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
NCT ID: NCT00676403
Last Updated: 2021-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2008-04-30
2009-01-31
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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1
Placebo
placebo
Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
2
investigational treatment
Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
3
investigational treatment
Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
4
investigational treatment
Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
5
investigational treatment
Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
6
investigational treatment
Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Interventions
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placebo
Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptoms occur predominantly in the evening
* symptoms interfere with sleep onset or maintenance
Exclusion Criteria
* require treatment for daytime RLS symptoms
* symptomatic neuropathies
18 Years
65 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
Tuscaloosa, Alabama, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Santa Monica, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Brandon, Florida, United States
Pfizer Investigational Site
Macon, Georgia, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Salisbury, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Alexandria, Virginia, United States
Pfizer Investigational Site
Innsbruck, , Austria
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Bad Saarow, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Göttingen, , Germany
Pfizer Investigational Site
Mittweida, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Oldenburg, , Germany
Pfizer Investigational Site
Schwerin, , Germany
Pfizer Investigational Site
Madrid, , Spain
Countries
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References
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Allen R, Chen C, Soaita A, Wohlberg C, Knapp L, Peterson BT, Garcia-Borreguero D, Miceli J. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med. 2010 Jun;11(6):512-9. doi: 10.1016/j.sleep.2010.03.003. Epub 2010 May 13.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081183
Identifier Type: -
Identifier Source: org_study_id
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