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

Phase 3

Withdrawn

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Placebo; Drug: pregabalin

• Registration Number: NCT01061372
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-03
• Study Start: 2010-05
• Status Verified: 2010-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

• Any secondary RLS
• Current augmentation due to RLS treatment
• Placebo responders identified during the placebo run-in

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pregabalin 150 mg/day	pregabalin	-
Pregabalin 300 mg/day	pregabalin	-

Primary Outcome Measures

Name	Time	Method
The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment	up to 12 weeks
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

Secondary Outcome Measures

Name	Time	Method
Impact on Life (IRLS symptom impact sub-score)	up to 12 weeks
Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide	up to 12 weeks
Subjective Sleep Questionnaire (SSQ - Subjective WASO)	up to 12 weeks
RLS Next Day Impact (RLS-NDI)	up to 12 weeks
Medical Outcomes Study - Sleep Scale (MOS - SS)	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
Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group	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
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
RLS-Quality of Life Scale (RLS-QoL)	up to 12 weeks