ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy
- Conditions
- Apatía en la Enfermedad de ParkinsonMedDRA version: 9.1Level: LLTClassification code 10061536Term: Parkinson's disease
- Registration Number
- EUCTR2007-004400-12-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and efficacy of rasagiline in patients with PD and apathy. <br>;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.<br>;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).
- Secondary Outcome Measures
Name Time Method