E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias |
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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 |
To assess the safety of the 5 mg BID dose of SCH 420814 in patients with Moderate to Severe Parkinson's Disease who are on a regimen of L-Dopa/dopa decarboxylase inhibitor and dopamine agonist by analyzing the proportion of patients reporting Adverse Events and abnormal laboratory analytes during the 36 weeks of open label treatment and comparing it to historical data. |
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E.2.2 | Secondary objectives of the trial |
Assess the duration of off time during and upon completion of the trial to its baseline. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must have participated in OR COMPLETED the parent Study P04501.
Subjects must be ≥30 years of age, of either sex and of any race, with a diagnosis of moderate to severe idiopathic Parkinson’s disease for at least 5 years.
Subjects must have been on a regimen of L-Dopa and a dopamine agonist.
Subjects must have a systolic BP ≤ 160 mm Hg and a diastolic BP ≤ 90 mm Hg.
Women of childbearing potential must have had a negative serum pregnancy test at Visit 1. If subject is postmenopausal (not surgically induced), she must be postmenopausal by history for at least 2 years before study entry. If not, proper birth control must be used.
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E.4 | Principal exclusion criteria |
Subjects who discontinued from the parent Study P04501 because they experienced a serious adverse event (SAE).
Subjects who discontinued from the parent Study P04501 because of elevated LFT test results.
Subjects with values of greater than the upper limit of normal (ULN) at Visit 1 for any of the following LFTs: alanine aminotransferase (ALT) (SGPT), aspartate aminotransferase (AST) (SGOT), gamma glutamyl transferase (GGT), alkaline phosphatase (ALK-P), and total bilirubin (T-BIL).
Average daily consumption of more than two 4-oz (120 mL) glasses of wine or their equivalent.
Elevated BP (systolic BP ≥160 mm Hg; OR diastolic BP ≥ 90 mm Hg).
Subjects who have received any prohibited treatment including potentially hepatotoxic drugs more recently than the indicated washout period prior to Visit 1. Women who are breast-feeding or who are considering breast-feeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
There is no primary efficacy endpoint. The primary safety endpoint is an assessment of the proportion of subjects reporting Adverse Events during the 36 weeks of open-label treatment compared to historical data.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |