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Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

NCT00558025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2014-05-16

Study results available
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Summary

The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

* To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
* To establish if this successful switch can be obtained with or without dose-adaptation;
* To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

Conditions

  • Parkinson Disease

Interventions

DRUG

Pramipexole Extended Release

DRUG

Pramipexole Immediate Release

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-05-31

Countries

  • France
  • Germany
  • Netherlands

Study Locations

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Entities

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 NCT00558025 on ClinicalTrials.gov