Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome
Intervention: placebo (Drug); Pregabalin (Drug); Pregabalin (Drug); Pregabalin (Drug); Pregabalin (Drug); Pregabalin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients
Clinical Details
Official title: Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
Secondary outcome: Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S) Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6 Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6 Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, Innsbruck A-6020, Austria
Pfizer Investigational Site, Vienna A-1080, Austria
Pfizer Investigational Site, Bad Saarow 15526, Germany
Pfizer Investigational Site, Berlin 10969, Germany
Pfizer Investigational Site, Goettingen 37075, Germany
Pfizer Investigational Site, Mittweida 09648, Germany
Pfizer Investigational Site, Muenchen 80331, Germany
Pfizer Investigational Site, Oldenburg 26122, Germany
Pfizer Investigational Site, Schwerin 19053, Germany
Pfizer Investigational Site, Madrid 28036, Spain
Pfizer Investigational Site, Tuscaloosa, Alabama 35406, United States
Pfizer Investigational Site, Little Rock, Arkansas 72205, United States
Pfizer Investigational Site, San Diego, California 92121, United States
Pfizer Investigational Site, Santa Monica, California 90404, United States
Pfizer Investigational Site, Aurora, Colorado 80012, United States
Pfizer Investigational Site, Brandon, Florida 33511, United States
Pfizer Investigational Site, Macon, Georgia 31201, United States
Pfizer Investigational Site, Louisville, Kentucky 40217, United States
Pfizer Investigational Site, Baton Rouge, Louisiana 70808, United States
Pfizer Investigational Site, Raleigh, North Carolina 27607, United States
Pfizer Investigational Site, Salisbury, North Carolina 28144, United States
Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States
Pfizer Investigational Site, Oklahoma City, Oklahoma 73112, United States
Pfizer Investigational Site, Dallas, Texas 75231, United States
Pfizer Investigational Site, Alexandria, Virginia 22311, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2008
Last updated: June 28, 2010
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