Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Condition(s) targeted: Idiopathic Restless Legs Syndrome

Intervention: placebo and pregabalin (Drug); pramipexol (Drug); pramipexol (Drug); Pregabalin (Drug); pramipexol (Drug); pramipexol (Drug)

Phase: Phase 3

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

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Official title: Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

RLS symptom severity using International RLS Severity Scale (IRLS)

Proportion of subjects responding to treatment using Clinical Global Impression - Improvement (CGI-I)

Rate of augmentation

Secondary outcome:

Subjective Sleep Questionnaire (SSQ)

RLS Quality of Life (RLS-QoL)

Augmentation Severity Rating Scale (ASRS)

Clinical Global Impression - Severity (CGI-S)

Medical Outcomes Study - Sleep Scale (MOS-SS)

Profile of Mood States (POMS)

Daytime Function - Patient Reported Outcome (DF-PRO)

Limb Pain - Numeriacl Rating Scale (Limb Pain - NRS)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- idiopathic RLS with the presence of all four clinical manifestations of RLS

- 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:

- Any secondary RLS

- Current augmentation due to RLS treatment

- Placebo responders identified during the placebo run-in

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

Pfizer Investigational Site, Innsbruck A-6020, Austria; Recruiting

Pfizer Investigational Site, Linz A-4021, Austria; Completed

Pfizer Investigational Site, Wien 1090, Austria; Recruiting

Pfizer Investigational Site, Helsinki 00420, Finland; Active, not recruiting

Pfizer Investigational Site, Kuopio 70210, Finland; Active, not recruiting

Pfizer Investigational Site, Tampere 33520, Finland; Active, not recruiting

Pfizer Investigational Site, Turku 20520, Finland; Active, not recruiting

Pfizer Investigational Site, Achim 28832, Germany; Recruiting

Pfizer Investigational Site, Bad Saarow 15526, Germany; Recruiting

Pfizer Investigational Site, Berlin 12683, Germany; Terminated

Pfizer Investigational Site, Berlin 13156, Germany; Recruiting

Pfizer Investigational Site, Berlin 10969, Germany; Recruiting

Pfizer Investigational Site, Berlin 10117, Germany; Recruiting

Pfizer Investigational Site, Berlin 12163, Germany; Recruiting

Pfizer Investigational Site, Berlin 10437, Germany; Recruiting

Pfizer Investigational Site, Berlin 10629, Germany; Recruiting

Pfizer Investigational Site, Berlin 10245, Germany; Recruiting

Pfizer Investigational Site, Berlin 10365, Germany; Recruiting

Pfizer Investigational Site, Bochum 44809, Germany; Recruiting

Pfizer Investigational Site, Bochum 44805, Germany; Recruiting

Pfizer Investigational Site, Bremen 28325, Germany; Recruiting

Pfizer Investigational Site, Dortmund 44229, Germany; Recruiting

Pfizer Investigational Site, Dresden 01307, Germany; Recruiting

Pfizer Investigational Site, Freiburg 79106, Germany; Recruiting

Pfizer Investigational Site, Gelsenkirchen 45879, Germany; Recruiting

Pfizer Investigational Site, Halle 06118, Germany; Active, not recruiting

Pfizer Investigational Site, Hamm 59065, Germany; Recruiting

Pfizer Investigational Site, Jena 07743, Germany; Recruiting

Pfizer Investigational Site, Juelich 52428, Germany; Recruiting

Pfizer Investigational Site, Kassel 34128, Germany; Recruiting

Pfizer Investigational Site, Kassel 34131, Germany; Recruiting

Pfizer Investigational Site, Koethen 06366, Germany; Recruiting

Pfizer Investigational Site, Leipzig 04107, Germany; Recruiting

Pfizer Investigational Site, Marburg 35039, Germany; Active, not recruiting

Pfizer Investigational Site, Muenchen 80331, Germany; Recruiting

Pfizer Investigational Site, Oldenburg 26122, Germany; Recruiting

Pfizer Investigational Site, Prien 83209, Germany; Recruiting

Pfizer Investigational Site, Schwerin 19053, Germany; Recruiting

Pfizer Investigational Site, Siegen 57072, Germany; Active, not recruiting

Pfizer Investigational Site, Ulm 89073, Germany; Active, not recruiting

Pfizer Investigational Site, Ulm 89081, Germany; Active, not recruiting

Pfizer Investigational Site, Unterhaching 82008, Germany; Recruiting

Pfizer Investigational Site, Westerstede 26655, Germany; Recruiting

Pfizer Investigational Site, Wuerzburg 97070, Germany; Recruiting

Pfizer Investigational Site, Pavia 27100, Italy; Recruiting

Pfizer Investigational Site, Pisa 56126, Italy; Recruiting

Pfizer Investigational Site, Rome 00163, Italy; Recruiting

Pfizer Investigational Site, Rome 00185, Italy; Recruiting

Pfizer Investigational Site, Troina 94018, Italy; Recruiting

Pfizer Investigational Site, Troina(EN) 94018, Italy; Recruiting

Pfizer Investigational Site, Ede 6716 RP, Netherlands; Active, not recruiting

Pfizer Investigational Site, Zwolle 8025 BV, Netherlands; Recruiting

Pfizer Investigational Site, Barcelona 08036, Spain; Recruiting

Pfizer Investigational Site, Barcelona 08035, Spain; Recruiting

Pfizer Investigational Site, Granada 18014, Spain; Active, not recruiting

Pfizer Investigational Site, Madrid 28036, Spain; Recruiting

Pfizer Investigational Site, Avesta 77482, Sweden; Terminated

Pfizer Investigational Site, Avesta SE-774 82, Sweden; Terminated

Pfizer Investigational Site, Göteborg 40530, Sweden; Recruiting

Pfizer Investigational Site, Göteborg 413 45, Sweden; Recruiting

Pfizer Investigational Site, Orebro 701 85, Sweden; Recruiting

Pfizer Investigational Site, Skovde SE-541 85, Sweden; Recruiting

Pfizer Investigational Site, Skovde 541 85, Sweden; Recruiting

Pfizer Investigational Site, Skövde 54185, Sweden; Recruiting

Pfizer Investigational Site, Stockholm 11245, Sweden; Recruiting

Pfizer Investigational Site, Örebro 70185, Sweden; Recruiting

Pfizer Investigational Site, Reading Berks RG2 0TG, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Birmingham, Alabama 35209, United States; Active, not recruiting

Pfizer Investigational Site, Jasper, Alabama 35501, United States; Active, not recruiting

Pfizer Investigational Site, Tuscaloosa, Alabama 35406, United States; Active, not recruiting

Pfizer Investigational Site, Glendale, Arizona 85308, United States; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85032, United States; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85050, United States; Recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States; Active, not recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72211, United States; Active, not recruiting

Pfizer Investigational Site, Northridge, California 91325, United States; Active, not recruiting

Pfizer Investigational Site, Redondo Beach, California 90277, United States; Active, not recruiting

Pfizer Investigational Site, San Diego, California 92121, United States; Active, not recruiting

Pfizer Investigational Site, San Diego, California 92103, United States; Active, not recruiting

Pfizer Investigational Site, Santa Monica, California 90404, United States; Active, not recruiting

Pfizer Investigational Site, Torrance, California 90502, United States; Active, not recruiting

Pfizer Investigational Site, Barcelona, Cataluña/Spain 08003, Spain; Recruiting

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

Pfizer Investigational Site, Boca Raton, Florida 33486, United States; Active, not recruiting

Pfizer Investigational Site, Hallandale Beach, Florida 33009, United States; Active, not recruiting

Pfizer Investigational Site, Miami, Florida 33143, United States; Active, not recruiting

Pfizer Investigational Site, Pembroke Pines, Florida 33026, United States; Active, not recruiting

Pfizer Investigational Site, South Miami, Florida 33143, United States; Active, not recruiting

Pfizer Investigational Site, Atlanta, Georgia 30342, United States; Active, not recruiting

Pfizer Investigational Site, Overland Park, Kansas 66212, United States; Active, not recruiting

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

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

Pfizer Investigational Site, Chevy Chase, Maryland 20815, United States; Active, not recruiting

Pfizer Investigational Site, Newton, Massachusetts 02459, United States; Active, not recruiting

Pfizer Investigational Site, Southfield, Michigan 48034, United States; Active, not recruiting

Pfizer Investigational Site, Minneapolis, Minnesota 55415, United States; Active, not recruiting

Pfizer Investigational Site, Princeton, New Jersey 08540, United States; Active, not recruiting

Pfizer Investigational Site, New York, New York 10019, United States; Active, not recruiting

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

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

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States; Active, not recruiting

Pfizer Investigational Site, Columbus, Ohio 43210, United States; Terminated

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

Pfizer Investigational Site, Lafayette Hill, Pennsylvania 19444, United States; Active, not recruiting

Pfizer Investigational Site, Austin, Texas 78756, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75231, United States; Active, not recruiting

Pfizer Investigational Site, Houston, Texas 77063, United States; Active, not recruiting

Pfizer Investigational Site, Plano, Texas 75093, United States; Active, not recruiting

Pfizer Investigational Site, Walla Walla, Washington 99362, United States; Active, not recruiting

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

Starting date: December 2008
Last updated: September 13, 2010