| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 13.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061536 |
| E.1.2 | Term | Parkinson's disease |
| E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
| 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 assess the long-term safety and tolerability of preladenant in subjects with moderate to severe Parkinson’s disease (PD). |
|
| E.2.2 | Secondary objectives of the trial |
| To characterize the long-term efficacy of preladenant in subjects with moderate to severe PD. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| Subjects must have completed P04938 or P07037. • Each subject (or subject’s legal representative) must be willing and able to provide written informed consent for the P06153. For a subject who is unable to provide independent consent, a legal representative may provide written informed consent. • Subjects must be able to adhere to dose and visit schedules. • Subjects must be taking levodopa (L-dopa). • Subjects may be taking any of the additional adjunct PD medications shown in the table below. Note: Subjects taking only L-dopa are permitted to enroll in this trial. Amantadine Anticholinergics Dopa decarboxylase inhibitors Dopamine agonists Entacapone L-dopa • Each subject must have results of clinical laboratory tests (hematology, blood chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator as evidenced by the last available test results from the parent study (P04938 or P07037), and no results fall within the parameters for exclusion described below in the exclusion criterion for liver-related findings. • There has been no change in, or there has been no finding to warrant checking, serology status (for cytomegalovirus [CMV], Epstein-Barr virus [EBV], and Hepatitis B, C, and E). Each subject must have results of a physical examination within normal limits, including blood pressure, within normal limits or clinically acceptable limits to the investigator, and not within the parameters for exclusion described below in the exclusion criterion for blood pressure. • All subjects that are sexually active or plan to be sexually active agree to use a highly effective method of birth control while the subject is in the study and for 2 weeks after the last dose of study drug. A male subject must not donate sperm within 2 weeks after the last dose of study drug. Complete details regarding contraceptive requirements are specified in protocol Section 7.7.1.7. |
|
| E.4 | Principal exclusion criteria |
| A subject must not have discontinued from P04938 or P07037 for any reason. • A subject must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence). • A subject must not have poorly controlled diabetes ( eg, HbA1c 8.5) or significantly abnormal renal function (eg, creatinine 2.0 mg/dL) in the opinion of the investigator. • As a continuation of the liver-related withdrawal criteria from the parent studies (P04938 and P07037), any subject with elevated values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (T-BIL), as evidenced by the most recent chemistry panel results in the parent study, meeting any one of the following criteria: • ALT or AST 8 x ULN. • ALT or AST 5 x ULN for more than 2 weeks. • ALT or AST 3 x ULN and (T-BIL 2 x ULN or international normalized ratio [INR] 1.5 that is not due to anti-coagulation) at the same visit. • ALT or AST 3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (5%). • As a continuation of the blood pressure (BP) withdrawal criteria from the parent studies (P04938 and P07037), any subject meeting the following criteria for the second of two consecutive visits separated by 7 days (ie, the subject met one of the BP criteria once already, 7 days before the P06153 Screening visit): • Systolic BP 180 mm Hg or diastolic BP 105 mm Hg, or • An elevation from Baseline BP in the parent study (P04938 or P07037) of systolic BP 40 mm Hg or diastolic BP 20 mm Hg. • A subject must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection. • A subject must not have an average daily consumption of more than three 4-ounce glasses (180 mL) of wine or the equivalent. • Prohibited Concomitant Medications: A subject should not take or start taking any treatment listed in the table below. A subject must not have received any treatment listed in the table below more recently than the indicated period before Day 1 of P06153. Note: Warnings and Contraindications detailed in the Prescribing Information for the allowed medications (shown in the inclusion criteria) must be followed.A subject must not have allergy/sensitivity to the investigational products or their excipients. • A female subject must not be breast-feeding or considering breast-feeding. • A female subject must not be pregnant or intending to become pregnant. • A subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Pre-specified safety endpoints, including the incidence of systolic BP 180 mm Hg, diastolic BP ≥105 mm Hg, ALT 3 x ULN with a ≥10% increase from Baseline, AST ≥3 x ULN with a ≥10% increase from Baseline, and Suicidality as measured by the CSSRS will be summarized by treatment group. 95% confidence intervals will be provided for the incidence rates using an Exact approach. |
|
| 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 | No |
| 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 | Yes |
| 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 73 |
| 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 |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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
|
| ultima visita dell`ultimo paziente |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| 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 | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
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