E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Parkinson`s diesease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
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 |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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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 | Yes |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |