Clinical Trial: Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

Brief Summary: To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 [ Time Frame: Baseline, Week 6 ]

IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.


Original Primary Outcome: International RLS Severity Scale (IRLS) [ Time Frame: 6 weeks ]

Current Secondary Outcome:

  • Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: Week 6 ]
    Clinical Global Impression - Improvement Scale (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. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.
  • Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S) [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF) ]
    CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
  • Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.
  • Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.
  • Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.
  • Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.
  • Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.
  • Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ]
    MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.
  • Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Chan

    Original Secondary Outcome:

    • Clinical Global Impression - Severity (CGI-S) [ Time Frame: 6 weeks ]
    • Medical Outcomes Study - Sleep Scale (MOSS-SS) [ Time Frame: 6 weeks ]
    • Adverse Events (AEs) [ Time Frame: 6 weeks ]
    • Clinical Global Impression - Improvement (CGI-I) [ Time Frame: 6 weeks ]


    Information By: Pfizer

    Dates:
    Date Received: May 8, 2008
    Date Started: April 2008
    Date Completion:
    Last Updated: June 28, 2010
    Last Verified: June 2010