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Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

NCT00577460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2014-05-16

Study results available
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Summary

The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).

Conditions

  • Parkinson Disease

Interventions

DRUG

Pramipexole

Pramipexole ER 0.375 -4.5 mg

DRUG

Placebo

Placebo tablets identical to Pramipexole ER tablets

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
32 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-06-30

Countries

  • Austria
  • Czechia
  • Hungary
  • India
  • Italy
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00577460 on ClinicalTrials.gov