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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

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.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: February 1, 2010
Date Started: May 2010
Date Completion: August 2011
Last Updated: June 28, 2010
Last Verified: June 2010