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Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

NCT00806026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 731

Last updated 2021-01-26

Study results available
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Summary

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Conditions

  • Idiopathic Restless Legs Syndrome

Interventions

DRUG

placebo and pregabalin

following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.

DRUG

pramipexol

following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.

DRUG

pramipexol

following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.

DRUG

Pregabalin

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

DRUG

pramipexol

pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

DRUG

pramipexol

pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

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
2008-12-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Austria
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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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 NCT00806026 on ClinicalTrials.gov