Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

Condition(s) targeted: Restless Legs Syndrome

Intervention: placebo (Drug); Pregabalin (Drug); Pregabalin (Drug); Pregabalin (Drug); Pregabalin (Drug); Pregabalin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Official title: Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: International RLS Severity Scale (IRLS)

Secondary outcome:

Clinical Global Impression - Severity (CGI-S)

Medical Outcomes Study - Sleep Scale (MOSS-SS)

Adverse Events (AEs)

Clinical Global Impression - Improvement (CGI-I)

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Moderate to severe idiopathic RLS

- symptoms occur predominantly in the evening

- symptoms interfere with sleep onset or maintenance

Exclusion Criteria:

- Any secondary RLS

- require treatment for daytime RLS symptoms

- symptomatic neuropathies

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Innsbruck A-6020, Austria; Active, not recruiting

Pfizer Investigational Site, Vienna A-1080, Austria; Active, not recruiting

Pfizer Investigational Site, Schwerin 19053, Germany; Active, not recruiting

Pfizer Investigational Site, Mittweida 09648, Germany; Active, not recruiting

Pfizer Investigational Site, Oldenburg 26122, Germany; Active, not recruiting

Pfizer Investigational Site, Muenchen 80331, Germany; Active, not recruiting

Pfizer Investigational Site, Bad Saarow 15526, Germany; Active, not recruiting

Pfizer Investigational Site, Berlin 10969, Germany; Active, not recruiting

Pfizer Investigational Site, Goettingen 37075, Germany; Active, not recruiting

Pfizer Investigational Site, MADRID 28036, Spain; Completed

Pfizer Investigational Site, Tuscaloosa, Alabama 35406, United States; Recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States; Recruiting

Pfizer Investigational Site, Santa Monica, California 90404, United States; Recruiting

Pfizer Investigational Site, San Diego, California 92121, United States; Recruiting

Pfizer Investigational Site, Aurora, Colorado 80012, United States; Active, not recruiting

Pfizer Investigational Site, Brandon, Florida 33511, United States; Recruiting

Pfizer Investigational Site, St Petersburg, Florida 33707, United States; Not yet recruiting

Pfizer Investigational Site, Macon, Georgia 31201, United States; Recruiting

Pfizer Investigational Site, Louisville, Kentucky 40217, United States; Recruiting

Pfizer Investigational Site, Baton Rouge, Louisiana 70808, United States; Recruiting

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States; Active, not recruiting

Pfizer Investigational Site, Raleigh, North Carolina 27607, United States; Active, not recruiting

Pfizer Investigational Site, Salisbury, North Carolina 28144, United States; Active, not recruiting

Pfizer Investigational Site, Oklahoma City, Oklahoma 73112, United States; Active, not recruiting

Pfizer Investigational Site, Dallas, Texas 75231, United States; Recruiting

Pfizer Investigational Site, Alexandria, Virginia 22311, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: March 2008
Ending date: January 2009
Last updated: January 16, 2009