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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061372
First Posted: February 3, 2010
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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
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

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 ]
  • 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 ]

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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061372


Sponsors and Collaborators
Pfizer
Investigators
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
First Submitted: February 1, 2010
First Posted: February 3, 2010
Last Update Posted: June 29, 2010
Last Verified: June 2010

Keywords provided by Pfizer:
RLS

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