E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Apatía en la Enfermedad de Parkinson |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and efficacy of rasagiline in patients with PD and apathy.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |