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Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists

NCT01007864 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-05-24

No results posted yet for this study

Summary

The purpose of this clinical trial is to investigate the effects of the non-ergot dopamine agonist piribedil on vigilance and cognitive performances in patients with Parkinson's disease in comparison with other oral non-ergot dopamine agonists.

It should be tested whether piribedil is superior to continued pramipexole or ropinirole treatment regarding improvement of reduced vigilance and cognitive performance in patients with Parkinson's disease.

Conditions

  • Idiopathic Parkinson's Disease

Interventions

DRUG

piribedil

Oral application of piribedil at an equivalent dose of pramipexole or ropinirole according to a defined equivalence scheme (dose range 100 - 300 mg per day) for 11 weeks.

DRUG

pramipexole or ropinirole

continuation of pre-study treatment regimen

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Desitin Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Martina Wangemann, Dr. · Desitin Arzneimittel GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Germany

Study Locations

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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 NCT01007864 on ClinicalTrials.gov