Parkinson's Disease Clinical Trial
Official title:
Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets
The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease
The pharmacokinetics of V1512 effervescent tablet has been evaluated in healthy volunteers,
however not fully in PD patients. This study aims to evaluate the PK profiles in PD patients
of different dosing schedules of V1512 effervescent tablet compared to the profiles after
standard L-dopa/carbidopa (Sinemet) over the course of the day. Two dosing schedules have
been chosen to evaluate a possible relation between dosing interval and 'ON' time, with and
without associated dyskinesia. Similar dosing schedules with the comparator Sinemet are
commonly employed in the treatment of fluctuating PD patients. Patients assigned to cohort 3
will also take a dose of entacapone concomitantly with each dose of V1512 or Sinemet,
thereby allowing the kinetics and dynamics of.V1512 and Sinemet to be compared in the
presence of COMT inhibition.
Safety and tolerability of the dosing regimens in patients will also be assessed further in
this double-blind study
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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