PER-098-07已完成未知
A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects must have participated in study P04501.
- •Subjects must be> 30 years of age, of any sex, and of any race, and have a diagnosis of idiopathic, moderate to severe Parkinson´s disease of at least 5 years.
- •Subjects must have been on an L-Dopa regimen and a dopamine agonist for at least 4 weeks prior to visit 1.
- •Subjects should have systolic BP <160 mm Hg and diastolic BP <90 mm Hg.
- •Women of childbearing age must have had a negative pregnancy serum test at visit 1. If the person is in the period after menopause (not surgically induced), they must have been through history, at least 2 years since menopause before I can enter the study. Otherwise, you must use a suitable method for birth control.
- •Clinical laboratory tests of the subjects (complete blood count, blood chemistries, and urinalysis) must be within normal or clinically acceptable limits for the investigator / sponsor.
- •A subject (or parent (s) / guardian) must be willing to give informed consent and be trained to comply with dose and visitation programs and study requirements.
排除标准
- •Subjects who were discontinued from study P04501 because they experienced a serious adverse event (SAE).
- •Subjects who were discontinued from study P04501 because the results of the LFT tests were high.
- •Subjects with values greater than the normal upper limit (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).
- •Subjects presenting any form of atypical or drug-induced parkinsonism, cognitive impairment, a history of major depressive episode, mild unstable depression or psychosis according to the diagnosis of DSM IV, or subjects taking tolcapone will be excluded from the study. (Subjects with mild depression, who are well controlled with stable doses of antidepressant medication for at least 4 weeks before the selection, will meet the eligibility conditions).
- •Average daily consumption of more than two glasses with 4 ounces (120 ml) of wine or its equivalents.
- •High TA (systolic BP> 160 mm Hg; O diastolic BP> 90 mm Hg).
- •Subjects who have received any prohibited treatment, including potentially hepatotoxic drugs (see Section 7.4.2.1.1), for a period more recent than the washout period indicated prior to visit 1 or those who have to continue receiving treatments listed in Table 3.
- •As it is not known if SCH 420814 passes into breast milk and since the effects of SCH 420814 (if any) on the developing human being are unknown, women who are breastfeeding or those who are considering doing so are excluded from this trial .
- •Subjects with allergy / sensitivity to the study drug or its excipients.
- •Subjects with any clinically significant condition or condition, other than the condition being studied that, in the opinion of the investigator, could interfere with the study´s assessments or with optimal participation in the study.
- •Subjects who are participating in some other clinical study.
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