Clinical trial NCT00676403: Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
Official title: Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
Keywords: pregabalin, RLS, efficacy, safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)
timeFrame: Week 6
measure: Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)
measure: Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline
timeFrame: Baseline,, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline
timeFrame: Baseline,, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6
measure: Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week
timeFrame: Week 1, Week 2, Week 4, Week 6
measure: Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6
timeFrame: Baseline, Week 6
measure: Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
timeFrame: Baseline, Week 6
measure: Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Brandon
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Alexandria
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Vienna
country: Austria
facility: Pfizer Investigational Site
city: Bad Saarow
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Mittweida
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Allen R, Chen C, Soaita A, Wohlberg C, Knapp L, Peterson BT, Garcia-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. doi: 10.1016/j.sleep.2010.03.003. Epub 2010 May 13.