Status:

COMPLETED

Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Restless Legs Syndrome

Eligibility:

All Genders

18+ years

Brief Summary

Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Detailed Description

Study Design:

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Moderate to severe Primary Restless Legs Syndrome
  • Male or female patients aged at least 18 years
  • Exclusion criteria:
  • Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
  • Ongoing treatment with Mirapex
  • Pregnant and breastfeeding women
  • Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
  • Secondary RLS

Exclusion

    Key Trial Info

    Start Date :

    December 1 2007

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    651 Patients enrolled

    Trial Details

    Trial ID

    NCT01170091

    Start Date

    December 1 2007

    Last Update

    April 11 2014

    Active Locations (36)

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    Page 1 of 9 (36 locations)

    1

    Boehringer Ingelheim Investigational Site 1

    Busan, South Korea

    2

    Boehringer Ingelheim Investigational Site 2

    Busan, South Korea

    3

    Boehringer Ingelheim Investigational Site 3

    Busan, South Korea

    4

    Boehringer Ingelheim Investigational Site 32

    Daegu, South Korea

    Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS | DecenTrialz