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

NCT01061372 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome

Interventions

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

DRUG

pregabalin

pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-08-31
Completion
2011-08-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061372 on ClinicalTrials.gov