E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | pref |
E.1.2 | Classification code | 10061536 |
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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 primary objective of this study is to assess the effect of early vs. later treatment with PPX in early PD.
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E.2.2 | Secondary objectives of the trial |
•Change in parts I, II, III UPDRS and in Motor and ADL components of UPDRS at 3, 6, 9 months and at 15 months relative to baseline •Change in mentation, behaviour and mood component of UPDRS at 3, 6, 9 months and at 15 months relative to baseline •Clinical response at 9 months and at 15 months •Severity of illness at 3, 6, 9, 12 and 15 months relative to baseline •BDI-IA total score at 3,6, 9 and 15 months relative to baseline •PDQ-39, EQ-VAS and EQ-5D at 6-9 and 15 months relative to baseline •Patient subset DAT SPECT brain imaging assessment at 15 months relative to baseline •Incidence and intensity of adverse events •Withdrawals due to adverse events •Change in vital signs (supine and standing - blood pressure and pulse rate) •Change in clinically significant clinical laboratory blood and urine determinations
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.)Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation; 2.)Male or female patient with idiopathic PD confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia); 3.)Parkinson’s disease newly diagnosed within the past 2 years; 4.)Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; 5.)Age 30 to 75 years at screening (Visit 1); 6.)Women of childbearing potential must have a negative serum Beta-HCG pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation ≥ 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermacide + diaphragm); and 7.)Patients who are 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 |
1.)Previous history of allergic response or complications with PPX or its excipients; 2.)Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilson's Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy); 3.)The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline; 4.)The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline; 5.)If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline; 6.)The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinson’s disease; 7.)The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinson’s disease; 8.)The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery); 9.)History of stereotactic brain surgery; 10.)Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patient’s participation in the study; 11.)History of active epilepsy (i.e., occurrence of a seizure) within the past year; 12.)Symptomatic orthostatic hypotension prior to randomization; 13.)Malignant melanoma or history of previously treated malignant melanoma; 14.)Patients who have received any of the following drugs (all time periods are calculated from randomization): •Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within the past 6 months •Monoamine oxidase (MAO) inhibitors in the past 3 months •Beta-blockers (e.g., propranolol) to treat PD in the past 30 days. (Beta blockers for other conditions are permitted) 15.)Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1); 16.)Patients who are currently pregnant or planning pregnancy during the study, or lactating; 17.)Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization; 18.)History of psychosis; 19.)A diagnosis of dementia; 20.)Mini-Mental State Exam (MMSE) total score < 24 at Screening (Visit 1); 21.)History of major depression and/or seasonal depression; 22.)History of drug or alcohol dependency within 6 months prior to signing the informed consent form; 23.)Inability to comply with the protocol 24.)Any other clinically significant medical or psychiatric condition or laboratory assay abnormality, which would interfere with the patient’s ability to participate in the study, increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is to determine the change in parts I, II, and III UPDRS at 15 months relative to baseline value as performed by an independent blinded rater |
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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 | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of life, DAT SPECT Imaging assessent |
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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) | 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
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E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Visit 15 which is the last visit |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |