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

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ClinicalTrials.gov Identifier: NCT00676403
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : February 4, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: placebo Drug: Pregabalin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Study Start Date : April 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: 1
Placebo
Drug: placebo
Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
Other Name: Sugar pill

Experimental: 2
investigational treatment
Drug: Pregabalin
50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Name: Lyrica, PD 0144723; CI-1008

Experimental: 3
investigational treatment
Drug: Pregabalin
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Name: Lyrica, PD 0144723; CI-1008

Experimental: 4
investigational treatment
Drug: Pregabalin
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Name: Lyrica, PD 0144723; CI-1008

Experimental: 5
investigational treatment
Drug: Pregabalin
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Name: Lyrica, PD 0144723; CI-1008

Experimental: 6
investigational treatment
Drug: Pregabalin
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Name: Lyrica, PD 0144723; CI-1008




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring 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; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.

  10. Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache 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 over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.

  11. Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy 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; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.

  12. Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence 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 over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.

  13. Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity 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 over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.

  14. Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; 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 over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.

  15. Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; 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 over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.

  16. Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week [ Time Frame: Week 1, Week 2, Week 4, Week 6 ]
    MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.

  17. Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
    RLS QoL: subject-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. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.

  18. Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
    Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.

  19. Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores [ Time Frame: Baseline, Week 6 ]
    Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from "much worse now" to much better now." Recall period: month prior to the assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe idiopathic RLS
  • symptoms occur predominantly in the evening
  • symptoms interfere with sleep onset or maintenance

Exclusion Criteria:

  • Any secondary RLS
  • require treatment for daytime RLS symptoms
  • symptomatic neuropathies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676403


  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Tuscaloosa, Alabama, United States, 35406
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
San Diego, California, United States, 92121
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
United States, Florida
Pfizer Investigational Site
Brandon, Florida, United States, 33511
United States, Georgia
Pfizer Investigational Site
Macon, Georgia, United States, 31201
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27607
Pfizer Investigational Site
Salisbury, North Carolina, United States, 28144
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
United States, Virginia
Pfizer Investigational Site
Alexandria, Virginia, United States, 22311
Austria
Pfizer Investigational Site
Innsbruck, Austria, A-6020
Pfizer Investigational Site
Vienna, Austria, A-1080
Germany
Pfizer Investigational Site
Bad Saarow, Germany, 15526
Pfizer Investigational Site
Berlin, Germany, 10969
Pfizer Investigational Site
Goettingen, Germany, 37075
Pfizer Investigational Site
Mittweida, Germany, 09648
Pfizer Investigational Site
Muenchen, Germany, 80331
Pfizer Investigational Site
Oldenburg, Germany, 26122
Pfizer Investigational Site
Schwerin, Germany, 19053
Spain
Pfizer Investigational Site
Madrid, Spain, 28036
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00676403     History of Changes
Other Study ID Numbers: A0081183
First Posted: May 13, 2008    Key Record Dates
Results First Posted: February 4, 2010
Last Update Posted: July 7, 2010
Last Verified: June 2010

Keywords provided by Pfizer:
pregabalin, RLS, efficacy, safety

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs