Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
NCT ID: NCT00991276
Last Updated: 2021-02-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
85 participants
INTERVENTIONAL
2009-12-31
2011-06-30
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.
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
NCT00373542
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
NCT00390689
A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
NCT00275236
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
NCT00356096
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
NCT00365352
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.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pregabalin
pregabalin
capsules; 300 mg once-per-day; 4 weeks of treatment
placebo
placebo
capsules; 0 mg once-per-day; 4 weeks of treatment
pramipexole
pramipexole
capsules; 0.5 mg once-per-day; 4 weeks of treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pregabalin
capsules; 300 mg once-per-day; 4 weeks of treatment
placebo
capsules; 0 mg once-per-day; 4 weeks of treatment
pramipexole
capsules; 0.5 mg once-per-day; 4 weeks of treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Jasper, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Burlingame, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
Redlands, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Santa Ana, California, United States
Pfizer Investigational Site
Santa Monica, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Hallandale, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
Spring Hill, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Macon, Georgia, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Crestview Hills, Kentucky, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, United States
Pfizer Investigational Site
Chevy Chase, Maryland, United States
Pfizer Investigational Site
Brighton, Massachusetts, United States
Pfizer Investigational Site
Kalamazoo, Michigan, United States
Pfizer Investigational Site
Portage, Michigan, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Hickory, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Dublin, Ohio, United States
Pfizer Investigational Site
Middleburg Heights, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Clarks Summit, Pennsylvania, United States
Pfizer Investigational Site
Lafayette Hill, Pennsylvania, United States
Pfizer Investigational Site
Columbia, South Carolina, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
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.
Garcia-Borreguero D, Patrick J, DuBrava S, Becker PM, Lankford A, Chen C, Miceli J, Knapp L, Allen RP. Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome. Sleep. 2014 Apr 1;37(4):635-43. doi: 10.5665/sleep.3558.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A0081185
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.