Patients with idiopathic Parkinson's Disease.
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration number: 125-
Trade Name: COMTAN
Pharmaceutical Form: Tablet
INN
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Idiopathic PD diagnosed according to the Gelb’s criteria; 2.Aged between 50-74 years; 3.Hoehn Yahr stage 1-2.5; 4.Ascertained dopaminergic response; 5.Willing and able to give written informed consent; 6.Willing and able to comply with the study procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms; 2.History of stereotaxic brain surgery for PD; 3.Mini-mental examination (MMSE) score less than 24 at screening; 4.Previous use of LD in any formulation for more than 3 months or for any time within 4 week prior to baseline; 5.Previous use of a DAs in any formulation for more than 3 months or for any time within 4 week prior to baseline; 6.Presence of dyskinesia prior to baseline; 7.Any other medical or psychiatric condition that may compromise the patient’s participation in this study; 8.Women with child-bearing potential; 9.History of known hypersensitivity to any of the study drugs; 10.Who for any reason would be expected to be unable to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the risk of dyskinesia in early PD patients treated with different modalities of LD administration (CLD, PLD and ILD) or pramipexole over a period of two years (24 months).;Secondary Objective: 1.Severity of dyskinesia; 2.Effect of treatments on the parkinsonian disability; 3.Effect of treatments on quality of life; 4.Effect of treatments on the progression of PD; 5.Incidence of wearing off; 6.Time to loss of the LDR; 7.Cumulative daily dosage of LD or Pramipexole needed to maintain an optimal LDR; 8.Percentage of patients requiring supplemental LD; 9.Incidence of adverse events; 10.Incidence of Impulsive Control disorder.;Primary end point(s): The primary outcome variable is defined as the time until the occurrence of dyskinesia. Dyskinesia will be considered to be present if a patient had a score of 1 or more at Unified Parkinson’s Disease Rating Scale (UPDRS) item 32 during any visit. Dyskinesia will be also assessed by blinded raters at the peak of the drug maximal efficacy by mean of Abnormal Involuntary Movements Scale (AIMS) and Clinical Dyskinesia Rating Scale (CDRS). Dyskinesia will be considered to be present if a patient had a score greater than 0. | — |
Countries
Italy
Contacts
Public ContactDipartimento di Neurologia
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO -VITTORIO EMANUELE
Outcome results
None listed