Clinical trial NCT00806026: Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Official title: Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Restless Legs Syndrome
Keywords: RLS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Restless Legs Syndrome (RLS) Symptom Severity
timeFrame: Baseline
measure: Change From Baseline in the RLS Symptom Severity at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Responding to Treatment at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Augmentation
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)
timeFrame: Baseline
measure: Change From Baseline in SSQ: Subjective WASO at Week 12
timeFrame: Baseline, Week 12
measure: Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12
timeFrame: Week 12
measure: Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12
timeFrame: Week 12
measure: Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12
timeFrame: Week 12
measure: Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12
timeFrame: Week 12
measure: RLS-Next Day Impact (RLS-NDI)
timeFrame: Baseline
measure: Change From Baseline in RLS-NDI at Week 12
timeFrame: Baseline, Week 12
measure: Limb Pain-Visual Analog Scale (Limb Pain-VAS)
timeFrame: Baseline
measure: Change From Baseline in Limb Pain-VAS at Week 12
timeFrame: Baseline, Week 12
measure: Severity of Augmentation Symptoms at Week 12
timeFrame: Week 12
measure: Clinical Global Impressions-Severity (CGI-S) at Week 12
timeFrame: Week 12
measure: Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12
timeFrame: Week 12
measure: Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12
timeFrame: Week 12
measure: Profile of Mood State (POMS) at Week 12
timeFrame: Week 12
measure: Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12
timeFrame: Week 12
measure: Medical Outcomes Study-Short Form 36 (SF-36) at Week 12
timeFrame: Week 12
measure: Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Jasper
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Northridge
country: United States
facility: Pfizer Investigational Site
state: California
city: Redondo Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Newton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Southfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Salisbury
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Lafayette Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Walla Walla
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Linz
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Achim
country: Germany
facility: Pfizer Investigational Site
city: Bad Saarow
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Bremen
country: Germany
facility: Pfizer Investigational Site
city: Dortmund
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Gelsenkirchen
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hamm
country: Germany
facility: Pfizer Investigational Site
city: Jena
country: Germany
facility: Pfizer Investigational Site
city: Juelich
country: Germany
facility: Pfizer Investigational Site
city: Kassel
country: Germany
facility: Pfizer Investigational Site
city: Kassel
country: Germany
facility: Pfizer Investigational Site
city: Koethen
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Prien
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Siegen
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Unterhaching
country: Germany
facility: Pfizer Investigational Site
city: Westerstede
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Rome
country: Italy
facility: Pfizer Investigational Site
city: Rome
country: Italy
facility: Pfizer Investigational Site
city: Troina(EN)
country: Italy
facility: Pfizer Investigational Site
city: Troina
country: Italy
facility: Pfizer Investigational Site
city: Ede
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
state: Cataluña/Spain
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Avesta
country: Sweden
facility: Pfizer Investigational Site
city: Avesta
country: Sweden
facility: Pfizer Investigational Site
city: Göteborg
country: Sweden
facility: Pfizer Investigational Site
city: Göteborg
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Skövde
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Örebro
country: Sweden
facility: Pfizer Investigational Site
city: Reading Berks
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Allen RP, Chen C, Garcia-Borreguero D, Polo O, DuBrava S, Miceli J, Knapp L, Winkelman JW. Comparison of pregabalin with pramipexole for restless legs syndrome. N Engl J Med. 2014 Feb 13;370(7):621-31. doi: 10.1056/NEJMoa1303646.