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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061372
First Posted: February 3, 2010
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
February 1, 2010
February 3, 2010
June 29, 2010
May 2010
August 2011   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01061372 on ClinicalTrials.gov Archive Site
  • Subjective Sleep Questionnaire (SSQ - Subjective WASO) [ Time Frame: up to 12 weeks ]
  • RLS Next Day Impact (RLS-NDI) [ Time Frame: up to 12 weeks ]
  • Limb pain rating using a numerical rating scale (Limb Pain - NRS) [ Time Frame: up to 12 weeks ]
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: up to 12 weeks ]
  • Medical Outcomes Study - Sleep Scale (MOS - SS) [ Time Frame: up to 12 weeks ]
  • Impact on Life (IRLS symptom impact sub-score) [ Time Frame: up to 12 weeks ]
  • RLS-Quality of Life Scale (RLS-QoL) [ Time Frame: up to 12 weeks ]
  • Medical Outcomes Study - Short Form 36 (SF-36) [ Time Frame: up to 12 weeks ]
  • Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) [ Time Frame: up to 12 weeks ]
  • Profile of Mood States (POMS) [ Time Frame: up to 12 weeks ]
  • Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group [ Time Frame: up to 12 weeks ]
  • Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide [ Time Frame: up to 12 weeks ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Restless Legs Syndrome
  • Drug: Placebo
    Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
  • Drug: pregabalin
    pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
    Other Name: Lyrica
  • Drug: pregabalin
    pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
    Other Name: Lyrica
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin 150 mg/day
    Intervention: Drug: pregabalin
  • Experimental: Pregabalin 300 mg/day
    Intervention: Drug: pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01061372
A0081184
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP