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Pivotal Study in Advanced Parkinsons Disease Patients

NCT00466167 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2014-07-08

Study results available
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Summary

The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations.

In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done.

The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

Conditions

  • Parkinson Disease

Interventions

DRUG

Pramipexol Extended Release

DRUG

Pramipexol Immediate Release

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
32 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-11-30

Countries

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

Study Locations

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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 NCT00466167 on ClinicalTrials.gov