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Levodopa Benserazide Generic Formulation Versus the Originator

NCT02741947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Levodopa Benserazide Madopar

Madopar 100+25mg and 200+50mg, tablet, tid e qid, for four weeks

DRUG

Levodopa Benserazide Teva Italia

Levodopa benserazide Teva 100+25mg and 200+50mg, tablet, tid e qid, for four weeks

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • IRCCS San Raffaele Roma

    lead OTHER

Principal Investigators

  • FABRIZIO STOCCHI, PROFESSOR · IRCCS San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

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 NCT02741947 on ClinicalTrials.gov