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

• ClinicalTrials.gov Identifier: NCT01061372
• Recruitment Status: Withdrawn
• First Posted: February 3, 2010
• Last Update Posted: January 22, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: February 1, 2010
• First Posted Date: February 3, 2010
• Last Update Posted Date: January 22, 2021
• Study Start Date: May 2010
• Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 1, 2010)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 1, 2010)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Restless Legs Syndrome

Intervention

• Drug: Placebo
  Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
• Drug: pregabalin
  pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
  Other Name: Lyrica
• Drug: pregabalin
  pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
  Other Name: Lyrica

Study Arms

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: Pregabalin 150 mg/day
  Intervention: Drug: pregabalin
• Experimental: Pregabalin 300 mg/day
  Intervention: Drug: pregabalin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: June 28, 2010): 0
• Original Estimated Enrollment (submitted: February 1, 2010): 350
• Estimated Study Completion Date: August 2011
• Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01061372
• Other Study ID Numbers: A0081184
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2010