Patients with Parkinson`s diesease MedDRA version: 12.0 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Rasagiline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical Form: Prolonged-release tablet
INN or
Sponsors
UNIVERSITA` DEGLI STUDI DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Duration of Parkinsons disease not longer than 24 months, Hoehn & Yahr stage I- II, patients age 40 to 75 ?Patients on current non ergot DAagonist treatment for not longer than 6 months for ropinirole and not longer than 5 months for pramipexole, at minimum daily dosage of 8 mg for the former and of 1.5 mg for the latter, maintained stable for at least 4 weeks, or patients previously untreated with DAergic drugs de novo patients ?To have given informed written consent to participate in the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ?Diagnosis of secondary Parkinsonism or atipical degenerative Parkinsonism ?Pregnant or suckling female patients ?History of alcohol or other substance abuse during the last 12 months ?Contra-indication to the use of the drugs investigated in the study ?Patients previously exposed to rasagiline or other Daergic drugs, as l-dopa, selegiline, amantadine, apomorphine, ergot-derived DAergic agonists. Patients treated with anticholinergics will be accepted if these drugs will be discontinued at least 3 weeks before inclusion ?Current or previous therapy with neuroleptics or other DA-antagonists ?Current or previous diagnosis of psychosis or current diagnosis of mood depression of moderate to severe degree (score of Beck Depression Inventory scale >17) to require or to have required antidepressant medication ?Patients with behaviour disturbances, such as medication-related altered impulse control, repetitive behaviours and dopamine dysregulation syndrome ?Patient cognitively impaired (Mini Mental State score < 24) ?Current or remitting neoplastic diseases and other diseases involving the central or peripheral nervous system ?Inclusion of the patient in other clinical study in which the use of the same or other drugs is scheduled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: This study project is aimed to assess in patients with early PD the long-term tolerability and efficacy of the combined therapy of the DA-agonist ropinirole and rasagiline, resulting from the possible neuroprotective action of the MAO-B inhibitor in conjunction with the symptomatic effect of the two drugs;Main Objective: The aim of this study is to investigate in patients with early Parkinsons disease the putative neuroprotective action of rasagiline as an add-on treatment to ongoing ropinirole therapy, by means of a delayed start design of the MAO-B inhibitor;Primary end point(s): Primary outcome measure will be considered the degree of motor impairment to require l-dopa therapy, as an index of disease progression. The degree of functional motor impairment to require l-dopa will be evaluated by means of UPDRS part II (total score higher than 15), Schwab & England scale (threshold value 70% of residual function in daily living activities, as compared to the condition preceding disease onset) and patients quality of life self-assessment (PDQ39) (total score higher than 30). At least two out of three above threshold values/scores have to be reached. | — |
Countries
Italy
Outcome results
None listed