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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
1.5 to 12 mg/day
0.75-4.5 mg/day
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
Change from baseline to endpoint in ON-time without dyskinesia
Time frame: 16 weeks
Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4
Time frame: 16 weeks
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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