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Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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: Completed

Sponsored by: Pfizer

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

Summary

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

Clinical Details

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:

Restless Legs Syndrome (RLS) Symptom Severity

Change From Baseline in the RLS Symptom Severity at Week 12

Percentage of Participants Responding to Treatment at Week 12

Percentage of Participants With Augmentation

Secondary outcome:

Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)

Change From Baseline in SSQ: Subjective WASO at Week 12

Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12

Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12

Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12

Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12

RLS-Next Day Impact (RLS-NDI)

Change From Baseline in RLS-NDI at Week 12

Limb Pain-Visual Analog Scale (Limb Pain-VAS)

Change From Baseline in Limb Pain-VAS at Week 12

Severity of Augmentation Symptoms at Week 12

Clinical Global Impressions-Severity (CGI-S) at Week 12

Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12

Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12

Profile of Mood State (POMS) at Week 12

Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12

Medical Outcomes Study-Short Form 36 (SF-36) at Week 12

Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12

Eligibility

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

Locations and Contacts

Pfizer Investigational Site, Innsbruck A-6020, Austria

Pfizer Investigational Site, Linz A-4021, Austria

Pfizer Investigational Site, Wien 1090, Austria

Pfizer Investigational Site, Helsinki 00420, Finland

Pfizer Investigational Site, Kuopio 70210, Finland

Pfizer Investigational Site, Tampere 33520, Finland

Pfizer Investigational Site, Turku 20520, Finland

Pfizer Investigational Site, Achim 28832, Germany

Pfizer Investigational Site, Bad Saarow 15526, Germany

Pfizer Investigational Site, Berlin 10629, Germany

Pfizer Investigational Site, Berlin 10245, Germany

Pfizer Investigational Site, Berlin 10365, Germany

Pfizer Investigational Site, Berlin 10437, Germany

Pfizer Investigational Site, Berlin 10969, Germany

Pfizer Investigational Site, Berlin 12163, Germany

Pfizer Investigational Site, Berlin 12683, Germany

Pfizer Investigational Site, Berlin 13156, Germany

Pfizer Investigational Site, Berlin 10117, Germany

Pfizer Investigational Site, Bochum 44787, Germany

Pfizer Investigational Site, Bochum 44805, Germany

Pfizer Investigational Site, Bremen 28325, Germany

Pfizer Investigational Site, Dortmund 44229, Germany

Pfizer Investigational Site, Dresden 01307, Germany

Pfizer Investigational Site, Freiburg 79106, Germany

Pfizer Investigational Site, Gelsenkirchen 45879, Germany

Pfizer Investigational Site, Halle 06118, Germany

Pfizer Investigational Site, Hamm 59065, Germany

Pfizer Investigational Site, Jena 07743, Germany

Pfizer Investigational Site, Juelich 52428, Germany

Pfizer Investigational Site, Kassel 34131, Germany

Pfizer Investigational Site, Kassel 34128, Germany

Pfizer Investigational Site, Koethen 06366, Germany

Pfizer Investigational Site, Leipzig 04107, Germany

Pfizer Investigational Site, Marburg 35039, Germany

Pfizer Investigational Site, Muenchen 80331, Germany

Pfizer Investigational Site, Oldenburg 26122, Germany

Pfizer Investigational Site, Prien 83209, Germany

Pfizer Investigational Site, Schwerin 19053, Germany

Pfizer Investigational Site, Siegen 57072, Germany

Pfizer Investigational Site, Ulm 89081, Germany

Pfizer Investigational Site, Ulm 89073, Germany

Pfizer Investigational Site, Unterhaching 82008, Germany

Pfizer Investigational Site, Westerstede 26655, Germany

Pfizer Investigational Site, Wuerzburg 97070, Germany

Pfizer Investigational Site, Pavia 27100, Italy

Pfizer Investigational Site, Pisa 56126, Italy

Pfizer Investigational Site, Rome 00163, Italy

Pfizer Investigational Site, Rome 00185, Italy

Pfizer Investigational Site, Troina(EN) 94018, Italy

Pfizer Investigational Site, Troina 94018, Italy

Pfizer Investigational Site, Ede 6716 RP, Netherlands

Pfizer Investigational Site, Zwolle 8025 BV, Netherlands

Pfizer Investigational Site, Barcelona 08035, Spain

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Granada 18014, Spain

Pfizer Investigational Site, Madrid 28036, Spain

Pfizer Investigational Site, Avesta 77482, Sweden

Pfizer Investigational Site, Avesta SE-774 82, Sweden

Pfizer Investigational Site, Göteborg 40530, Sweden

Pfizer Investigational Site, Göteborg 413 45, Sweden

Pfizer Investigational Site, Orebro 701 85, Sweden

Pfizer Investigational Site, Skovde 541 85, Sweden

Pfizer Investigational Site, Skovde SE-541 85, Sweden

Pfizer Investigational Site, Skövde 54185, Sweden

Pfizer Investigational Site, Stockholm 11245, Sweden

Pfizer Investigational Site, Örebro 70185, Sweden

Pfizer Investigational Site, Reading Berks RG2 0TG, United Kingdom

Pfizer Investigational Site, Birmingham, Alabama 35209, United States

Pfizer Investigational Site, Jasper, Alabama 35501, United States

Pfizer Investigational Site, Tuscaloosa, Alabama 35406, United States

Pfizer Investigational Site, Glendale, Arizona 85308, United States

Pfizer Investigational Site, Phoenix, Arizona 85032, United States

Pfizer Investigational Site, Phoenix, Arizona 85050, United States

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

Pfizer Investigational Site, Little Rock, Arkansas 72211, United States

Pfizer Investigational Site, Northridge, California 91325, United States

Pfizer Investigational Site, Redondo Beach, California 90277, United States

Pfizer Investigational Site, San Diego, California 92103, United States

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

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

Pfizer Investigational Site, Torrance, California 90502, United States

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

Pfizer Investigational Site, Aurora, Colorado 80012, United States

Pfizer Investigational Site, Boca Raton, Florida 33486, United States

Pfizer Investigational Site, Hallandale Beach, Florida 33009, United States

Pfizer Investigational Site, Miami, Florida 33143, United States

Pfizer Investigational Site, Pembroke Pines, Florida 33026, United States

Pfizer Investigational Site, South Miami, Florida 33143, United States

Pfizer Investigational Site, Atlanta, Georgia 30342, United States

Pfizer Investigational Site, Overland Park, Kansas 66212, United States

Pfizer Investigational Site, Louisville, Kentucky 40217, United States

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

Pfizer Investigational Site, Chevy Chase, Maryland 20815, United States

Pfizer Investigational Site, Newton, Massachusetts 02459, United States

Pfizer Investigational Site, Southfield, Michigan 48034, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55415, United States

Pfizer Investigational Site, Princeton, New Jersey 08540, United States

Pfizer Investigational Site, New York, New York 10019, United States

Pfizer Investigational Site, Salisbury, North Carolina 28144-0000, United States

Pfizer Investigational Site, Salisbury, North Carolina 28144, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Columbus, Ohio 43210, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma 73112, United States

Pfizer Investigational Site, Lafayette Hill, Pennsylvania 19444, United States

Pfizer Investigational Site, Austin, Texas 78731, United States

Pfizer Investigational Site, Dallas, Texas 75231, United States

Pfizer Investigational Site, Houston, Texas 77063, United States

Pfizer Investigational Site, Plano, Texas 75093, United States

Pfizer Investigational Site, Walla Walla, Washington 99362, United States

Additional Information

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

Starting date: December 2008
Last updated: August 27, 2012

Page last updated: August 23, 2015

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