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A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.
Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a minimum 1-week screening period, a 4-week switch and stabilization period and an 8-week maintenance period. The second part of the study will be open label pardoprunox treatment with a dose adjustment period of 4 weeks followed by long term maintenance treatment.
Age
30 - No limit years
Sex
ALL
Healthy Volunteers
No
Site Reference ID/Investigator# 45433
Göttingen, Germany
Site Reference ID/Investigator# 45428
Kassel, Germany
Site Reference ID/Investigator# 45422
Tübingen, Germany
Site Reference ID/Investigator# 45427
Ulm, Germany
Site Reference ID/Investigator# 45435
Cassino, Italy
Site Reference ID/Investigator# 45436
Chieti Scalo, Italy
Site Reference ID/Investigator# 45437
Rome, Italy
Site Reference ID/Investigator# 45438
Coimbra, Portugal
Site Reference ID/Investigator# 45439
Lisbon, Portugal
Start Date
September 1, 2009
Primary Completion Date
May 1, 2011
Completion Date
May 1, 2011
Last Updated
August 26, 2011
37
ACTUAL participants
pardoprunox
DRUG
pramipexole
DRUG
Lead Sponsor
Abbott Products
NCT00501969
NCT00407095
Data Source & Attribution
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