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12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

Primary Purpose

Restless Legs Syndrome

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
pregabalin
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:
  • RLS symptoms occur predominantly in the evening
  • RLS history at least 6 months
  • International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in
  • Have greater than or equal to 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo

    Pregabalin 150 mg/day

    Pregabalin 300 mg/day

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment
    The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment

    Secondary Outcome Measures

    Subjective Sleep Questionnaire (SSQ - Subjective WASO)
    RLS Next Day Impact (RLS-NDI)
    Limb pain rating using a numerical rating scale (Limb Pain - NRS)
    Clinical Global Impressions - Severity (CGI-S)
    Medical Outcomes Study - Sleep Scale (MOS - SS)
    Impact on Life (IRLS symptom impact sub-score)
    RLS-Quality of Life Scale (RLS-QoL)
    Medical Outcomes Study - Short Form 36 (SF-36)
    Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP)
    Profile of Mood States (POMS)
    Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group
    Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide
    Changes in RLS symptoms following the discontinuation of study drug at the end of treatment will be evaluated by collection of the IRLS scores at the end of the drug taper period at Week 13

    Full Information

    First Posted
    February 1, 2010
    Last Updated
    January 21, 2021
    Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01061372
    Brief Title
    12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
    Official Title
    Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2010
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    August 2011 (Anticipated)
    Study Completion Date
    August 2011 (Anticipated)

    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
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Pregabalin 150 mg/day
    Arm Type
    Experimental
    Arm Title
    Pregabalin 300 mg/day
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    pregabalin
    Other Intervention Name(s)
    Lyrica
    Intervention Description
    pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
    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 weeks
    Primary Outcome Measure Information:
    Title
    Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment
    Time Frame
    up to 12 weeks
    Title
    The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Subjective Sleep Questionnaire (SSQ - Subjective WASO)
    Time Frame
    up to 12 weeks
    Title
    RLS Next Day Impact (RLS-NDI)
    Time Frame
    up to 12 weeks
    Title
    Limb pain rating using a numerical rating scale (Limb Pain - NRS)
    Time Frame
    up to 12 weeks
    Title
    Clinical Global Impressions - Severity (CGI-S)
    Time Frame
    up to 12 weeks
    Title
    Medical Outcomes Study - Sleep Scale (MOS - SS)
    Time Frame
    up to 12 weeks
    Title
    Impact on Life (IRLS symptom impact sub-score)
    Time Frame
    up to 12 weeks
    Title
    RLS-Quality of Life Scale (RLS-QoL)
    Time Frame
    up to 12 weeks
    Title
    Medical Outcomes Study - Short Form 36 (SF-36)
    Time Frame
    up to 12 weeks
    Title
    Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP)
    Time Frame
    up to 12 weeks
    Title
    Profile of Mood States (POMS)
    Time Frame
    up to 12 weeks
    Title
    Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group
    Time Frame
    up to 12 weeks
    Title
    Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide
    Time Frame
    up to 12 weeks
    Title
    Changes in RLS symptoms following the discontinuation of study drug at the end of treatment will be evaluated by collection of the IRLS scores at the end of the drug taper period at Week 13
    Time Frame
    week 13

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS: RLS symptoms occur predominantly in the evening RLS history at least 6 months International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in Have greater than or equal to 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

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081184&StudyName=12-Week%20Efficacy%20And%20Safety%20Of%20Pregabalin%20In%20Treating%20Restless%20Legs%20Syndrome%20%28RLS%29%20Subjects
    Description
    To obtain contact information for a study center near you, click here.

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    12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

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