Levodopa Benserazide Generic Formulation Versus the Originator
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The trial was an experimental two-centers, randomized, double-blind, two-sequence,
non-inferiority cross-over study.
Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to
participate in the study entered a 4 weeks period if not on stable regimen of Madopar®
(run-in period). Following the run-in period, there were two maintenance periods of 4 weeks
each, for a total duration of 8 weeks.
Patients were assigned randomly (1:1) by a computerized randomization system to one of two
formulation sequences maintaining the dose stabilized during the run in:
- generic-originator
- originator-generic At the end of maintenance period 1, the patients in each formulation
group underwent an overnight switch to the same dose of the alternative formulation. The
dose was kept stable during the whole length of trial. Clinical evaluations were
performed at the end of each period. The tablets were encapsulated to maintain the
blindness.
A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14
subjects.
Population: out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5
years, receiving L-dopa/benserazide.
The total duration of the trial was approximately 8 weeks for patient divided in two
maintenance periods of 4 weeks each.
Phase:
Phase 4
Details
Lead Sponsor:
IRCCS San Raffaele
Collaborator:
Agenzia Italiana del Farmaco
Treatments:
Benserazide Benserazide, levodopa drug combination Levodopa