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

Primary Purpose

Idiopathic Restless Legs Syndrome

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

placebo and pregabalin

pramipexol

Pregabalin

pramipexol

About this trial

This is an interventional treatment trial for Idiopathic Restless Legs Syndrome focused on measuring RLS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

PBO/PGB 300 mg

PBO/PPX 0.25 mg

PBO/PPX 0.5 mg

PGB 300 mg

PPX 0.25 mg

PPX 0.5 mg

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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".

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.

Secondary Outcome Measures

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.

Change From Baseline in SSQ: Subjective WASO at 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.

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.

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.

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.

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.

Change From Baseline in RLS-NDI at 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT00806026

First Posted

December 9, 2008

Last Updated

January 22, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00806026

Brief Title

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Acronym

RLS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Restless Legs Syndrome

Keywords

RLS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

731 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PBO/PGB 300 mg

Arm Type

Experimental

Arm Title

PBO/PPX 0.25 mg

Arm Type

Active Comparator

Arm Title

PBO/PPX 0.5 mg

Arm Type

Active Comparator

Arm Title

PGB 300 mg

Arm Type

Experimental

Arm Title

PPX 0.25 mg

Arm Type

Active Comparator

Arm Title

PPX 0.5 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

placebo and pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

pramipexol

Other Intervention Name(s)

Mirapex

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

pramipexol

Other Intervention Name(s)

Mirapex

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Intervention Type

Drug

Intervention Name(s)

pramipexol

Other Intervention Name(s)

Mirapex

Intervention Description

pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Intervention Type

Drug

Intervention Name(s)

pramipexol

Other Intervention Name(s)

Mirapex

Intervention Description

pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Primary Outcome Measure Information:

Title

Restless Legs Syndrome (RLS) Symptom Severity

Description

Time Frame

Baseline

Title

Change From Baseline in the RLS Symptom Severity at Week 12

Description

Time Frame

Baseline, Week 12

Title

Percentage of Participants Responding to Treatment at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants With Augmentation

Description

Time Frame

Baseline up to Week 52

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline

Title

Change From Baseline in SSQ: Subjective WASO at Week 12

Description

Time Frame

Baseline, Week 12

Title

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

Description

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.

Time Frame

Week 12

Title

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

Description

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.

Time Frame

Week 12

Title

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

Description

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.

Time Frame

Week 12

Title

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

Description

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.

Time Frame

Week 12

Title

RLS-Next Day Impact (RLS-NDI)

Description

Time Frame

Baseline

Title

Change From Baseline in RLS-NDI at Week 12

Description

Time Frame

Baseline, Week 12

Title

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

Description

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.

Time Frame

Baseline

Title

Change From Baseline in Limb Pain-VAS at Week 12

Description

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.

Time Frame

Baseline, Week 12

Title

Severity of Augmentation Symptoms at Week 12

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

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

Description

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.

Time Frame

Week 12

Title

Profile of Mood State (POMS) at Week 12

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Pfizer Investigational Site

City

Jasper

State/Province

Alabama

ZIP/Postal Code

35501

Country

United States

Facility Name

Pfizer Investigational Site

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35406

Country

United States

Facility Name

Pfizer Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

Pfizer Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Pfizer Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Pfizer Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Pfizer Investigational Site

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Pfizer Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Pfizer Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

Pfizer Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Pfizer Investigational Site

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Pfizer Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Pfizer Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Pfizer Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

Pfizer Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Pfizer Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Pfizer Investigational Site

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Pfizer Investigational Site

City

Newton

State/Province

Massachusetts

ZIP/Postal Code

02459

Country

United States

Facility Name

Pfizer Investigational Site

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Pfizer Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

Facility Name

Pfizer Investigational Site

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Pfizer Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144-0000

Country

United States

Facility Name

Pfizer Investigational Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Pfizer Investigational Site

City

Lafayette Hill

State/Province

Pennsylvania

ZIP/Postal Code

19444

Country

United States

Facility Name

Pfizer Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77063

Country

United States

Facility Name

Pfizer Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Pfizer Investigational Site

City

Walla Walla

State/Province

Washington

ZIP/Postal Code

99362

Country

United States

Facility Name

Pfizer Investigational Site

City

Innsbruck

ZIP/Postal Code

A-6020

Country

Austria

Facility Name

Pfizer Investigational Site

City

Linz

ZIP/Postal Code

A-4021

Country

Austria

Facility Name

Pfizer Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Pfizer Investigational Site

City

Helsinki

ZIP/Postal Code

00420

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Pfizer Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Pfizer Investigational Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Pfizer Investigational Site

City

Achim

ZIP/Postal Code

28832

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bad Saarow

ZIP/Postal Code

15526

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10245

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10365

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10437

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12683

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

13156

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bochum

ZIP/Postal Code

44805

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bremen

ZIP/Postal Code

28325

Country

Germany

Facility Name

Pfizer Investigational Site

City

Dortmund

ZIP/Postal Code

44229

Country

Germany

Facility Name

Pfizer Investigational Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Pfizer Investigational Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Pfizer Investigational Site

City

Gelsenkirchen

ZIP/Postal Code

45879

Country

Germany

Facility Name

Pfizer Investigational Site

City

Halle

ZIP/Postal Code

06118

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamm

ZIP/Postal Code

59065

Country

Germany

Facility Name

Pfizer Investigational Site

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Pfizer Investigational Site

City

Juelich

ZIP/Postal Code

52428

Country

Germany

Facility Name

Pfizer Investigational Site

City

Kassel

ZIP/Postal Code

34128

Country

Germany

Facility Name

Pfizer Investigational Site

City

Kassel

ZIP/Postal Code

34131

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koethen

ZIP/Postal Code

06366

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04107

Country

Germany

Facility Name

Pfizer Investigational Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

80331

Country

Germany

Facility Name

Pfizer Investigational Site

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Pfizer Investigational Site

City

Prien

ZIP/Postal Code

83209

Country

Germany

Facility Name

Pfizer Investigational Site

City

Schwerin

ZIP/Postal Code

19053

Country

Germany

Facility Name

Pfizer Investigational Site

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Pfizer Investigational Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Pfizer Investigational Site

City

Westerstede

ZIP/Postal Code

26655

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wuerzburg

ZIP/Postal Code

97070

Country

Germany

Facility Name

Pfizer Investigational Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Pfizer Investigational Site

City

Rome

ZIP/Postal Code

00163

Country

Italy

Facility Name

Pfizer Investigational Site

City

Rome

ZIP/Postal Code

00185

Country

Italy

Facility Name

Pfizer Investigational Site

City

Troina(EN)

ZIP/Postal Code

94018

Country

Italy

Facility Name

Pfizer Investigational Site

City

Troina

ZIP/Postal Code

94018

Country

Italy

Facility Name

Pfizer Investigational Site

City

Ede

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Zwolle

ZIP/Postal Code

8025 BV

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Barcelona

State/Province

Cataluña/Spain

ZIP/Postal Code

08003

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Pfizer Investigational Site

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28036

Country

Spain

Facility Name

Pfizer Investigational Site

City

Avesta

ZIP/Postal Code

77482

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Avesta

ZIP/Postal Code

SE-774 82

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Göteborg

ZIP/Postal Code

40530

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Orebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Skovde

ZIP/Postal Code

541 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Skovde

ZIP/Postal Code

SE-541 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Skövde

ZIP/Postal Code

54185

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Stockholm

ZIP/Postal Code

11245

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Örebro

ZIP/Postal Code

70185

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Reading Berks

ZIP/Postal Code

RG2 0TG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24521108

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081186&StudyName=Long%20Term%20Study%20Of%20Pregabalin%20In%20Idiopathic%20Restless%20Legs%20Syndrome%20Patients

Description

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Learn more about this trial

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

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

Idiopathic Restless Legs Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial