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Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

NCT00676403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2021-02-10

Study results available
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Summary

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

placebo

Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks

DRUG

Pregabalin

50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

DRUG

Pregabalin

100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

DRUG

Pregabalin

150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

DRUG

Pregabalin

300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

DRUG

Pregabalin

450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States
  • Austria
  • Germany
  • Spain

Study Locations

More Related Trials

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 NCT00676403 on ClinicalTrials.gov