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

This study has been withdrawn prior to enrollment.
Information provided by:
ClinicalTrials.gov Identifier:
First received: February 1, 2010
Last updated: June 28, 2010
Last verified: June 2010
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 Intervention Phase
Restless Legs Syndrome
Drug: Placebo
Drug: pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective Sleep Questionnaire (SSQ - Subjective WASO) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • RLS Next Day Impact (RLS-NDI) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Limb pain rating using a numerical rating scale (Limb Pain - NRS) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study - Sleep Scale (MOS - SS) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Impact on Life (IRLS symptom impact sub-score) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • RLS-Quality of Life Scale (RLS-QoL) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study - Short Form 36 (SF-36) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Profile of Mood States (POMS) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: week 13 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lyrica


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061372

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01061372     History of Changes
Other Study ID Numbers: A0081184 
Study First Received: February 1, 2010
Last Updated: June 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Anti-Anxiety Agents
Calcium Channel Blockers
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 30, 2016