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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: pregabalin; Drug: pregabalin

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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; Drug: pregabalin; pregabalin 300 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 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks; Other Names: Lyrica; Drug: pregabalin; pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks; Other Names: Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ANTICIPATED): August 1, 2011
• Study Completion (ANTICIPATED): August 1, 2011

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (ESTIMATE): February 3, 2010

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: RLS
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081184