Phase 2 N=137 Randomized Double-blind Treatment

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

Restless Legs Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00676403 ↗

Enrolled (actual)

137

Serious AEs

0.7%

Results posted

Feb 2010

Primary outcome: Primary: Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 — -7.73; -11.83; -11.76; -16.02 scores on scale — p=0.0983

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: placebo (Drug); Pregabalin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6	-7.73; -11.83; -11.76; -16.02; -12.89; -16.26	0.0983
SECONDARY Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)	13; 12; 15; 11; 17; 18	0.8784
SECONDARY Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)	0; 0; 0; 0; 0; 0	0.3876
SECONDARY Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline	-9.8; -16.3; -13.2; -10.4; -9.1; -20.2	0.4133
SECONDARY Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline	0.23; 0.57; 0.29; 0.55; 0.45; 0.72	0.1715
SECONDARY Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline	-0.5; -0.9; -1.0; -1.2; -0.7; -0.8	0.1429
SECONDARY Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline	-23.8; -37.9; -28.5; -29.0; -32.2; -32.6	0.1860
SECONDARY Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline	5.0; 18.8; 15.2; 15.9; 11.5; 17.2	0.0199 sig
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline	-9.0; -18.2; -21.1; -23.0; -17.7; -26.3	0.1824
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline	-2.4; 5.2; -8.6; 0.7; -2.9; -9.2	0.3368
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline	-7.3; -1.7; -5.3; -9.2; -8.6; 1.4	0.2719
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline	5.2; 16.1; 5.3; 13.7; 9.8; 16.1	0.1673
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline	-7.4; -13.8; -9.8; -14.3; -11.2; -10.7	0.2817
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline	0.4; 0.7; 0.5; 0.9; 0.4; 0.7	0.2978
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline	-9.2; -12.5; -10.4; -14.9; -13.9; -16.2	0.5409
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline	-8.1; -15.9; -14.2; -17.8; -14.4; -18.8	0.1547
SECONDARY Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week	6; 10; 7; 9; 6; 11	0.0646
SECONDARY Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6	15.0; 19.6; 22.4; 20.8; 15.9; 20.5	0.3932
SECONDARY Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6	3.6; 0.5; 2.4; -0.4; 2.9; 3.6	0.5384
SECONDARY Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores	0; 3; 1; 2; 3; 2	0.4452

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00676403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.