E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson disease |
Malattia di Parkinson |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 |
Primary objective Primary objective: To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on motor symptoms.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on selected non motor symptoms : • sleep quality • depression • cognitive function
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age ≥70 years -Idiopathic PD confirmed by at least two of the following signs: resting tremor, bradikynesia, rigidity -Diagnosis of PD within the last 12 months and onset of symptoms within 12 months from diagnosis -Disease stage I or II according to Hoehn and Yahr Scale -Ability to provide written informed consent -Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
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E.4 | Principal exclusion criteria |
-Disease duration more than 12 months since diagnosis and/or duration of symptoms at diagnosis for more than 12 months -Hoehn & Yahr stage ≥3 -Atypical or secondary parkinsonism -Patient currently on L-dopa, DA or other PD medication at baseline -Centrally acting dopaminergic agents, MAOIs, tolcapone, budipine, neuroleptics taken within the 28 days preceding the baseline visit -History of deep brain stimulation -History of severe cardiac disease/heart failure in the last 3 years -History of repeated falls -History of sulfite sensitivity -Arterial hypotension -Stroke or a transient ischemic attack within the last 12 months -Previous or current treatment with rotigotine (at any time) -Diagnosis of dementia according to DSM-IV-R -Mini mental State Examination (MMSE) total score <24 at screening visit -History of psychosis - Clinically relevant hepatic dysfunction and/or transaminase levels 5+ times higher than upper normal value -Experimental treatments within the antecedent 3 months -History of drug or alcohol dependency -Poor compliance with treatment -Inability to comply with protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the two treatment groups in the percentage of responders at 4 months. Responders is the improvement of at least 20% in the sum of scores UPDRS part 2 and 3 |
Confronto dei due gruppi di trattamento nella percentuale di responders a 4 Mesi. Responders è il miglioramento di almeno 20% nella somma degli scores UPDRS parte 2 e 3 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Comparison between the two treatment groups in the percentage of responders to visit 4 and 6 in scores of stairs PDSS-2 and GDS |
Confronto tra i due gruppi di trattamento nella percentuale di responders alla visita 4 e 6 negli scores delle scale PDSS-2 e GDS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline, V4 and v6 |
Baseline, V4, V6 |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 7 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |