Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients (RLS)

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

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Restless Legs Syndrome
• Intervention / Treatment: Drug: placebo and pregabalin; Drug: pramipexol; Drug: pramipexol; Drug: pramipexol; Drug: pramipexol; Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 731
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Pfizer Investigational Site
  • Linz, Austria, A-4021
    • Pfizer Investigational Site
  • Wien, Austria, 1090
    • Pfizer Investigational Site
• Finland
  • Helsinki, Finland, 00420
    • Pfizer Investigational Site
  • Kuopio, Finland, 70210
    • Pfizer Investigational Site
  • Tampere, Finland, 33520
    • Pfizer Investigational Site
  • Turku, Finland, 20520
    • Pfizer Investigational Site
• Germany
  • Achim, Germany, 28832
    • Pfizer Investigational Site
  • Bad Saarow, Germany, 15526
    • Pfizer Investigational Site
  • Berlin, Germany, 10117
    • Pfizer Investigational Site
  • Berlin, Germany, 10629
    • Pfizer Investigational Site
  • Berlin, Germany, 10245
    • Pfizer Investigational Site
  • Berlin, Germany, 10365
    • Pfizer Investigational Site
  • Berlin, Germany, 10437
    • Pfizer Investigational Site
  • Berlin, Germany, 10969
    • Pfizer Investigational Site
  • Berlin, Germany, 12163
    • Pfizer Investigational Site
  • Berlin, Germany, 12683
    • Pfizer Investigational Site
  • Berlin, Germany, 13156
    • Pfizer Investigational Site
  • Bochum, Germany, 44787
    • Pfizer Investigational Site
  • Bochum, Germany, 44805
    • Pfizer Investigational Site
  • Bremen, Germany, 28325
    • Pfizer Investigational Site
  • Dortmund, Germany, 44229
    • Pfizer Investigational Site
  • Dresden, Germany, 01307
    • Pfizer Investigational Site
  • Freiburg, Germany, 79106
    • Pfizer Investigational Site
  • Gelsenkirchen, Germany, 45879
    • Pfizer Investigational Site
  • Halle, Germany, 06118
    • Pfizer Investigational Site
  • Hamm, Germany, 59065
    • Pfizer Investigational Site
  • Jena, Germany, 07743
    • Pfizer Investigational Site
  • Juelich, Germany, 52428
    • Pfizer Investigational Site
  • Kassel, Germany, 34128
    • Pfizer Investigational Site
  • Kassel, Germany, 34131
    • Pfizer Investigational Site
  • Koethen, Germany, 06366
    • Pfizer Investigational Site
  • Leipzig, Germany, 04107
    • Pfizer Investigational Site
  • Marburg, Germany, 35039
    • Pfizer Investigational Site
  • Muenchen, Germany, 80331
    • Pfizer Investigational Site
  • Oldenburg, Germany, 26122
    • Pfizer Investigational Site
  • Prien, Germany, 83209
    • Pfizer Investigational Site
  • Schwerin, Germany, 19053
    • Pfizer Investigational Site
  • Siegen, Germany, 57072
    • Pfizer Investigational Site
  • Ulm, Germany, 89073
    • Pfizer Investigational Site
  • Ulm, Germany, 89081
    • Pfizer Investigational Site
  • Unterhaching, Germany, 82008
    • Pfizer Investigational Site
  • Westerstede, Germany, 26655
    • Pfizer Investigational Site
  • Wuerzburg, Germany, 97070
    • Pfizer Investigational Site
• Italy
  • Pavia, Italy, 27100
    • Pfizer Investigational Site
  • Pisa, Italy, 56126
    • Pfizer Investigational Site
  • Rome, Italy, 00163
    • Pfizer Investigational Site
  • Rome, Italy, 00185
    • Pfizer Investigational Site
  • Troina, Italy, 94018
    • Pfizer Investigational Site
  • Troina(EN), Italy, 94018
    • Pfizer Investigational Site
• Netherlands
  • Ede, Netherlands, 6716 RP
    • Pfizer Investigational Site
  • Zwolle, Netherlands, 8025 BV
    • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • Pfizer Investigational Site
  • Barcelona, Spain, 08036
    • Pfizer Investigational Site
  • Granada, Spain, 18014
    • Pfizer Investigational Site
  • Madrid, Spain, 28036
    • Pfizer Investigational Site
  • Cataluña/Spain
    • Barcelona, Cataluña/Spain, Spain, 08003
      • Pfizer Investigational Site
• Sweden
  • Avesta, Sweden, 77482
    • Pfizer Investigational Site
  • Avesta, Sweden, SE-774 82
    • Pfizer Investigational Site
  • Göteborg, Sweden, 413 45
    • Pfizer Investigational Site
  • Göteborg, Sweden, 40530
    • Pfizer Investigational Site
  • Orebro, Sweden, 701 85
    • Pfizer Investigational Site
  • Skovde, Sweden, 541 85
    • Pfizer Investigational Site
  • Skovde, Sweden, SE-541 85
    • Pfizer Investigational Site
  • Skövde, Sweden, 54185
    • Pfizer Investigational Site
  • Stockholm, Sweden, 11245
    • Pfizer Investigational Site
  • Örebro, Sweden, 70185
    • Pfizer Investigational Site
• United Kingdom
  • Reading Berks, United Kingdom, RG2 0TG
    • Pfizer Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Pfizer Investigational Site
    • Jasper, Alabama, United States, 35501
      • Pfizer Investigational Site
    • Tuscaloosa, Alabama, United States, 35406
      • Pfizer Investigational Site
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85032
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85050
      • Pfizer Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Pfizer Investigational Site
    • Little Rock, Arkansas, United States, 72211
      • Pfizer Investigational Site
  • California
    • Northridge, California, United States, 91325
      • Pfizer Investigational Site
    • Redondo Beach, California, United States, 90277
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
    • San Diego, California, United States, 92121
      • Pfizer Investigational Site
    • Santa Monica, California, United States, 90404
      • Pfizer Investigational Site
    • Torrance, California, United States, 90502
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Pfizer Investigational Site
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Pfizer Investigational Site
    • Hallandale Beach, Florida, United States, 33009
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33143
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33026
      • Pfizer Investigational Site
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Pfizer Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pfizer Investigational Site
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Pfizer Investigational Site
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Pfizer Investigational Site
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Pfizer Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Pfizer Investigational Site
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10019
      • Pfizer Investigational Site
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Pfizer Investigational Site
    • Salisbury, North Carolina, United States, 28144-0000
      • Pfizer Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43210
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Pfizer Investigational Site
  • Pennsylvania
    • Lafayette Hill, Pennsylvania, United States, 19444
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78731
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75231
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77063
      • Pfizer Investigational Site
    • Plano, Texas, United States, 75093
      • Pfizer Investigational Site
  • Washington
    • Walla Walla, Washington, United States, 99362
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBO/PGB 300 mg	Drug: placebo and pregabalin; following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Lyrica
Active Comparator: PBO/PPX 0.25 mg	Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex
Active Comparator: PBO/PPX 0.5 mg	Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex
Experimental: PGB 300 mg	Drug: Pregabalin; pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Lyrica
Active Comparator: PPX 0.25 mg	Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex
Active Comparator: PPX 0.5 mg	Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex; Drug: pramipexol; pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months; Other Names: Mirapex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restless Legs Syndrome (RLS) Symptom Severity	International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.	Baseline
Change From Baseline in the RLS Symptom Severity at Week 12	IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.	Baseline, Week 12
Percentage of Participants Responding to Treatment at Week 12	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of "very much improved" or "much improved".	Week 12
Percentage of Participants With Augmentation	Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.	Baseline up to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.	Baseline
Change From Baseline in SSQ: Subjective WASO at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.	Baseline, Week 12
Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.	Week 12
Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep.	Week 12
Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep.	Week 12
Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12	SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep.	Week 12
RLS-Next Day Impact (RLS-NDI)	The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.	Baseline
Change From Baseline in RLS-NDI at Week 12	The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.	Baseline, Week 12
Limb Pain-Visual Analog Scale (Limb Pain-VAS)	100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.	Baseline
Change From Baseline in Limb Pain-VAS at Week 12	100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean.	Baseline, Week 12
Severity of Augmentation Symptoms at Week 12	ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.	Week 12
Clinical Global Impressions-Severity (CGI-S) at Week 12	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.	Week 12
Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12	MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes.	Week 12
Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12	MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes.	Week 12
Profile of Mood State (POMS) at Week 12	POMS are participant-rated instrument comprising 6 sub-scales (tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment) and each subscale comprising 5 items, on 'How you feel right now?' (Scale: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for vigor-activity. A total score is obtained for each scale. The range of total score is 0 - 100, with higher score indicating more mood disturbance.	Week 12
Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12	RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life.	Week 12
Medical Outcomes Study-Short Form 36 (SF-36) at Week 12	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from "0=much worse now" to "4=much better now". Higher subscale and summary score reflect better health status.	Week 12
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12	WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity.	Week 12

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 10, 2008

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: RLS
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Protective Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Dopamine Agonists; Dopamine Agents; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pregabalin; Pramipexole
• Other Study ID Numbers: A0081186