Levodopa Benserazide Generic Formulation Versus the Originator

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Collaborator: Agenzia Italiana del Farmaco
• Treatments: Benserazide; Benserazide, levodopa drug combination; Levodopa

Criteria

Inclusion Criteria

Out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa/benserazide, were enrolled to participate into the study. The patients were recruited within the patient population using the hospitals out-patients clinics.

• Subject must be ≥30 and ≤75 years of age, of either sex and of any race.

• Diagnosis of Parkinson's disease

• Subjects in Hoehn and Yahr stages 2 to 4.

• Subject must have good response to levodopa (≥30% improvement in the UPDRS score).

• Subject must have been on a stable regimen of L-dopa for at least 4 month before Screening.

• A female subject must be postmenopausal, or sterile or use a medically accepted method of contraception.

Fragile population was included in the trial (Elderly 65-74 years and over 75 years).

Exclusion Criteria

• Atypical Parkinsonism

• Subjects with very severe motor fluctuations and/or dyskinesias.

• Significant internal-medicine or psychiatric diseases.

• Subject's clinical laboratory tests outside the normal ranges.

• History of previous rhabdomyolysis

• Subjects in therapy with Catechol-O-methyltransferase-inhibitor.

• Subjects who participated in any other clinical trial in the 4 months before the screening.

• Any subject who is pregnant or breastfeeding.

• Subjects demented or not able to give informed consent to trial