Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Launched by PFIZER'S UPJOHN HAS MERGED WITH MYLAN TO FORM VIATRIS INC. · Oct 6, 2009
Trial Information
Current as of June 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS).
- • RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months.
- • PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs.
- Exclusion Criteria:
- • Secondary RLS.
- • Daytime RLS symptoms requiring treatment.
- • Primary sleep disorder.
- • Sleep apnea.
- • Night or shift work.
- • Concurrent medical disorder that could interfere with efficacy assessment or present a safety concern.
- • Pregnant or lactating women.
- • Women of child-bearing potential not using acceptable method of birth control.
- • Use of prohibited medication.
About Pfizer's Upjohn Has Merged With Mylan To Form Viatris Inc.
Viatris Inc. is a global healthcare company formed from the merger of Pfizer's Upjohn division and Mylan, dedicated to providing access to high-quality medicines, including generics and specialty pharmaceuticals. With a strong commitment to innovation and patient-centric solutions, Viatris leverages a diverse portfolio and extensive global reach to address the evolving healthcare needs of patients worldwide. The company aims to create sustainable healthcare solutions by combining expertise in pharmaceutical development, manufacturing, and distribution, ultimately enhancing patient outcomes and improving overall health systems.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Santa Monica, California, United States
Atlanta, Georgia, United States
Crestview Hills, Kentucky, United States
Winston Salem, North Carolina, United States
Little Rock, Arkansas, United States
Tucson, Arizona, United States
Aurora, Colorado, United States
Raleigh, North Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
San Diego, California, United States
Phoenix, Arizona, United States
Redlands, California, United States
Macon, Georgia, United States
Oklahoma City, Oklahoma, United States
Chevy Chase, Maryland, United States
Columbia, South Carolina, United States
Baton Rouge, Louisiana, United States
Santa Ana, California, United States
Spring Hill, Florida, United States
Hallandale Beach, Florida, United States
Portage, Michigan, United States
Hickory, North Carolina, United States
Overland Park, Kansas, United States
Miami, Florida, United States
Cincinnati, Ohio, United States
Kalamazoo, Michigan, United States
Middleburg Heights, Ohio, United States
New York, New York, United States
Pembroke Pines, Florida, United States
Brighton, Massachusetts, United States
Pasadena, California, United States
Lexington, Kentucky, United States
Clarks Summit, Pennsylvania, United States
Jasper, Alabama, United States
Lafayette Hill, Pennsylvania, United States
Burlingame, California, United States
Dublin, Ohio, United States
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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