Phase 3 N=325 Randomized Double-blind Treatment

XP13512 vs. Placebo in Patients With Restless Legs Syndrome.

Restless Legs Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00365352 ↗

Enrolled (actual)

325

Serious AEs

0.9%

Results posted

May 2011

Primary outcome: Primary: Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) — -9.8; -13.0 scores on a scale — p=0.0015

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: XP13512 600MG (Drug); XP13512 1200MG (Drug); PLACEBO (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: XenoPort, Inc.
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)	-9.8; -13.0	0.0015 sig
PRIMARY Number of Participants With a Score of "Much Improved" or "Very Much Improved" on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF	43; 86	0.0001 sig
SECONDARY Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF	-9.8; -13.8	—
SECONDARY Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF	43; 83	—
SECONDARY Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF	13; 36; 40	—
SECONDARY The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I	NA; 4.1; 2.1	—
SECONDARY Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF	-8.8; -13.7; -12.5; -13.3; -12.4; -17.1	—
SECONDARY Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF	-6.3; -8.9; -7.9; -8.5; -11.9; -8.8	—
SECONDARY Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF	-6.0; -9.8; -8.7	—
SECONDARY Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF	26; 54; 57; 5; 9; 13	—
SECONDARY Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment	26; 54; 59	—
SECONDARY Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF	0.6; 0.7; 1.0	—
SECONDARY Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF	-12.5; -16.4; -18.5	—
SECONDARY Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF	-1.7; -2.5; -2.6	—
SECONDARY Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF	48; 75; 76; 41; 62; 66	—
SECONDARY Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF	-2.3; -3.5; -3.5	—
SECONDARY Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)	46; 90; 83; 20; 55; 52	—
SECONDARY Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF	14; 24; 30	—
SECONDARY Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF	19; 35; 39	—
SECONDARY Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF	-7.3; -10.9; -11.5	—
SECONDARY Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF	-9.7; -9.8; -16.1	—
SECONDARY Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF	-17.0; -29.5; -30.7	—
SECONDARY Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF	13.6; 29.1; 27.7	—
SECONDARY Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF	0.3; 0.6; 0.8	—
SECONDARY Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF	14.5; 19.3; 20.4	—
SECONDARY Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)	52; 85; 74; 51; 74; 69	—
SECONDARY Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)	12.8; 13.5; 13.8	—

Summary

The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Eligibility Criteria

Inclusion Criteria

Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.

Exclusion Criteria

A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
Pregnant or lactating women;
Women of childbearing potential who are not practicing an acceptable method of birth control.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00365352). 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.