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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

Page last updated: August 23, 2015

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