Levodopa Benserazide Generic Formulation Versus the Originator

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2024
• Main ID: NCT02741947
• Date of registration: 31/03/2016
• Prospective Registration: No
• Primary sponsor: IRCCS San Raffaele Roma
• Public title: Levodopa Benserazide Generic Formulation Versus the Originator FARM9X59Y4
• Scientific title: Clinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®)
• Date of first enrolment: April 2014
• Target sample size: 44
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02741947
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: FABRIZIO STOCCHI, PROFESSOR
• Affiliation: IRCCS San Raffaele

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Levodopa Benserazide Madopar

Drug: Levodopa Benserazide Teva Italia

Primary Outcome(s)

Change in bioequivalence in the total Area Under the Curve (AUC-t) between the generic levodopa/benserazide and the originator. [Time Frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)]

Change in therapeutic equivalence measured with the Unified Parkinson's Disease rating scale part III between the generic levodopa/benserazide and the originator. [Time Frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)]

Secondary Outcome(s)

Change in bioequivalence in minimum concentration (Cmin) between the generic levodopa/benserazide and the originator. [Time Frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)]

Change in bioequivalence in time to maximum concentration (Tmax) after the last dose between the generic levodopa/benserazide and the originator. [Time Frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)]

Change in bioequivalence in the half life (t 1/2) after the last dose between the generic levodopa/benserazide and the originator. [Time Frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)]

Change in Patient Clinical Global Impression - Global Improvement scale between the generic levodopa/benserazide and the originator. [Time Frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)]

Secondary ID(s)

RP 13/12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Agenzia Italiana del Farmaco