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

  Purpose

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

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: placebo Drug: Pregabalin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs Sleep Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

• 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 ] [ Designated as safety issue: No ]
  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:

• Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  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) ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 Change From Baseline [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline [ Time Frame: Baseline,, Week 1, Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week [ Time Frame: Week 1, Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  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.
  
  

Enrollment:	137
Study Start Date:	April 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

  Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676403

  Show 25 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

  More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Allen R, Chen C, Soaita A, Wohlberg C, Knapp L, Peterson BT, García-Borreguero D, Miceli J. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med. 2010 Jun;11(6):512-9. Epub 2010 May 13.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00676403     History of Changes
Other Study ID Numbers:	A0081183
Study First Received:	May 8, 2008
Results First Received:	January 8, 2010
Last Updated:	June 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

pregabalin, RLS, efficacy, safety

Additional relevant MeSH terms:

Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders

Neurobehavioral Manifestations Signs and Symptoms Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants

ClinicalTrials.gov processed this record on June 18, 2013

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