12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01061372

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: Placebo Drug: pregabalin Drug: pregabalin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

Study Start Date :

May 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
Experimental: Pregabalin 150 mg/day	Drug: pregabalin pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks Other Names: Lyrica
Experimental: Pregabalin 300 mg/day	Drug: pregabalin pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks Other Names: Lyrica

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks

Experimental: Pregabalin 150 mg/day

Drug: pregabalin

pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks

Other Names:

Lyrica

Experimental: Pregabalin 300 mg/day

Drug: pregabalin

pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks

Other Names:

Lyrica

Outcome Measures

Primary Outcome Measures

Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment [up to 12 weeks]
The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment [up to 12 weeks]

Secondary Outcome Measures

Subjective Sleep Questionnaire (SSQ - Subjective WASO) [up to 12 weeks]
RLS Next Day Impact (RLS-NDI) [up to 12 weeks]
Limb pain rating using a numerical rating scale (Limb Pain - NRS) [up to 12 weeks]
Clinical Global Impressions - Severity (CGI-S) [up to 12 weeks]
Medical Outcomes Study - Sleep Scale (MOS - SS) [up to 12 weeks]
Impact on Life (IRLS symptom impact sub-score) [up to 12 weeks]
RLS-Quality of Life Scale (RLS-QoL) [up to 12 weeks]
Medical Outcomes Study - Short Form 36 (SF-36) [up to 12 weeks]
Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) [up to 12 weeks]
Profile of Mood States (POMS) [up to 12 weeks]
Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group [up to 12 weeks]
Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide [up to 12 weeks]
Changes in RLS symptoms following the discontinuation of study drug at the end of treatment will be evaluated by collection of the IRLS scores at the end of the drug taper period at Week 13 [week 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:
RLS symptoms occur predominantly in the evening
RLS history at least 6 months
International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in
Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening