Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias
Conditions
Interventions
Product Name: SCH 420814
Product Code: N/A
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
Schering Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Assess the duration of off time during and upon completion of the trial to its baseline.;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. | — |
Countries
France, Spain
Outcome results
None listed