A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A
- Conditions
- Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias
- Registration Number
- EUCTR2007-001717-42-FR
- Lead Sponsor
- Schering Plough Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method