- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00676403
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Innsbruck, Austria, A-6020
- Pfizer Investigational Site
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Vienna, Austria, A-1080
- Pfizer Investigational Site
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Bad Saarow, Germany, 15526
- Pfizer Investigational Site
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Berlin, Germany, 10969
- Pfizer Investigational Site
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Goettingen, Germany, 37075
- Pfizer Investigational Site
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Mittweida, Germany, 09648
- Pfizer Investigational Site
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Muenchen, Germany, 80331
- Pfizer Investigational Site
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Oldenburg, Germany, 26122
- Pfizer Investigational Site
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Schwerin, Germany, 19053
- Pfizer Investigational Site
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Madrid, Spain, 28036
- Pfizer Investigational Site
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Alabama
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Tuscaloosa, Alabama, United States, 35406
- Pfizer Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Pfizer Investigational Site
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California
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San Diego, California, United States, 92121
- Pfizer Investigational Site
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Santa Monica, California, United States, 90404
- Pfizer Investigational Site
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Colorado
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Aurora, Colorado, United States, 80012
- Pfizer Investigational Site
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Florida
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Brandon, Florida, United States, 33511
- Pfizer Investigational Site
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Georgia
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Macon, Georgia, United States, 31201
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40217
- Pfizer Investigational Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pfizer Investigational Site
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North Carolina
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Raleigh, North Carolina, United States, 27607
- Pfizer Investigational Site
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Salisbury, North Carolina, United States, 28144
- Pfizer Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States, 75231
- Pfizer Investigational Site
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Virginia
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Alexandria, Virginia, United States, 22311
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: 1
Placebo
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Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
Other Names:
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EXPERIMENTAL: 2
investigational treatment
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50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
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EXPERIMENTAL: 3
investigational treatment
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50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
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EXPERIMENTAL: 4
investigational treatment
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50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
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EXPERIMENTAL: 5
investigational treatment
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50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
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EXPERIMENTAL: 6
investigational treatment
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50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Baseline, Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)
Time Frame: Week 6
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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.
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Week 6
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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)
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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.
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Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)
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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
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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.
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Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 4, Week 6
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Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6
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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.
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Baseline, Week 1, Week 2, Week 4, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 4, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 4, Week 6
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Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline
Time Frame: Baseline,, Week 1, Week 2, Week 4, Week 6
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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.
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Baseline,, Week 1, Week 2, Week 4, Week 6
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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
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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.
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Baseline,, Week 1, Week 2, Week 4, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 4, Week 6
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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
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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.
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Baseline, Week 1, Week 2, Week 4, Week 6
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Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week
Time Frame: Week 1, Week 2, Week 4, Week 6
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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.
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Week 1, Week 2, Week 4, Week 6
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Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6
Time Frame: Baseline, Week 6
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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.
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Baseline, Week 6
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Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Time Frame: Baseline, Week 6
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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.
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Baseline, Week 6
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Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Time Frame: Baseline, Week 6
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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.
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Baseline, Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ACTUAL)
January 1, 2009
Study Completion (ACTUAL)
January 1, 2009
Study Registration Dates
First Submitted
May 8, 2008
First Submitted That Met QC Criteria
May 12, 2008
First Posted (ESTIMATE)
May 13, 2008
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2021
Last Update Submitted That Met QC Criteria
January 21, 2021
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Syndrome
- Psychomotor Agitation
- Restless Legs Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- A0081183
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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