CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)

• Conditions: PARKINSON'S DISEASE; MedDRA version: 16.0Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001245-40-IT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-17
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Population: 60 out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa, will be enrolled to participate into the study. The study will be performed in hospital setting using the facilities of the clinical trial centre in both sites involved in the study. The patients will be recruited within the patient population using the hospitals out-patients clinics. Recruitment timing will be 12 months.
Inclusion Criteria:
° Subject must be >=30 and <=75 years of age, of either sex and of any race.
° Diagnosis of Parkinson's disease
° Subjects must be 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 rabdomiolysis.
° Subjects in therapy with COMT-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified