Clinical trial NCT01061372: 12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
Official title: Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: RLS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment
timeFrame: up to 12 weeks
measure: The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Subjective Sleep Questionnaire (SSQ - Subjective WASO)
timeFrame: up to 12 weeks
measure: RLS Next Day Impact (RLS-NDI)
timeFrame: up to 12 weeks
measure: Limb pain rating using a numerical rating scale (Limb Pain - NRS)
timeFrame: up to 12 weeks
measure: Clinical Global Impressions - Severity (CGI-S)
timeFrame: up to 12 weeks
measure: Medical Outcomes Study - Sleep Scale (MOS - SS)
timeFrame: up to 12 weeks
measure: Impact on Life (IRLS symptom impact sub-score)
timeFrame: up to 12 weeks
measure: RLS-Quality of Life Scale (RLS-QoL)
timeFrame: up to 12 weeks
measure: Medical Outcomes Study - Short Form 36 (SF-36)
timeFrame: up to 12 weeks
measure: Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP)
timeFrame: up to 12 weeks
measure: Profile of Mood States (POMS)
timeFrame: up to 12 weeks
measure: Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group
timeFrame: up to 12 weeks
measure: Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide
timeFrame: up to 12 weeks
measure: 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
timeFrame: week 13
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: