Levodopa Benserazide Generic Formulation Versus the Originator
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson, Therapeutic Equivalence, Levodopa
Eligibility 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
Sites / Locations
- Irccs San Raffaele Pisana
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Levodopa Benserazide Madopar
Levodopa Benserazide Teva Italia
Madopar 100+25mg and 200+50mg, tablet, tid e qid, for four weeks
Levodopa Benserazide Teva Italia100+25mg and 200+50mg, tablet, tid e qid, for four weeks