Apatía en la Enfermedad de Parkinson MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: Azilect
Pharmaceutical Form: Tablet
INN or Proposed INN: RASAGILINE
CAS Number: 136236516
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceuti
Sponsors
Institut de Recerca de l'Hospital de la santa Creu i Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with idiopathic PD (Hughes, Ben-Shlomo et al. 1992) optimally treated for their motor deficits with stable doses of L-Dopa and/or dopamine agonists and showing a non-zero score on the apathy item of the Neuropsychiatric Inventory (complaining of lack of initiative, lack of interest and of emotional blunting). Both, patients with stable and wearing-off response (e.g., consistent and predictable reappearance of motor symptoms prior to the next dose of oral LD) will be included. 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: Excluded will be subjects: accomplishing criteria for dementia associated to PD according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (Code 294.1); with a score = 24 on the Mini-Mental State Examination (MMSE) (Folstein, Folstein et al. 1975); with history of primary psychiatric illness or Axis I diagnoses according to the Structured Clinical Interview for DSM-IV; those complaining of acute mood or cognitive fluctuations in response to dopaminergic medication; and those treated with any MAO inhibitor (including Selegiline), fluoxetine and fluvoxamine during the previous month before inclusion. Subjects with previous surgery for PD, stroke, clinically significant renal disease or with creatinine level higher than upper limit of normal (ULN) range at the screening, clinically significant hepatic disease or with GPT level >2 times the upper limit of normal range at the screening and patients with other clinically significant metabolic/endocrine, haematological, gastro-intestinal or pulmonary disease, or poorly controlled cardiovascular disease (including hypotension and serious coronary artery disease); patients with a history of or clinical signs for any form of epilepsy or seizures (except fever-related seizures in early childhood).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of rasagiline in patients with PD and apathy. ;Secondary Objective: 1) To evaluate the affective and cognitive response to rasagiline and their correlates to apathy. 2) To investigate the metabolic and neurophysiologic correlates of the behavioural, cognitive and emotional, aspects of apathy in PD. ;Primary end point(s): The primary efficacy measure will be the mean change from baseline to study endpoint (week 12) in apathy scores as measured by the Lille Apathy Rating Scale (LARS). | — |
Countries
Spain
Outcome results
None listed