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Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

NCT00601523 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2014-06-09

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 ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).

Conditions

  • Parkinson Disease

Interventions

DRUG

Placebo

Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.

DRUG

Pramipexole

ER 0.375-4,5 mg

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-06-30

Countries

  • United States
  • Austria
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Japan
  • Malaysia
  • Netherlands
  • Russia
  • Slovakia
  • Taiwan
  • Ukraine

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 NCT00601523 on ClinicalTrials.gov