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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2010
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 3, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJanuary 22, 2021
June 1, 2010
1.3 years
February 1, 2010
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
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
- +8 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPregabalin 150 mg/day
EXPERIMENTALPregabalin 300 mg/day
EXPERIMENTALInterventions
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any secondary RLS
- Current augmentation due to RLS treatment
- Placebo responders identified during the placebo run-in
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 3, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 22, 2021
Record last verified: 2010-06