None listed
Conditions
Interventions
SCH 420814 Type of group
5 mg BID of SCH 420814 for 36 weeks
Sponsors
SCHERING PLOUGH DEL PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:To assess the proportion of subjects reporting adverse events during the 36 weeks of open treatment. Measure:Proportion of subjects reporting adverse events during the 36 weeks Timepoints:36 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The off time is the time during which the symptoms worsen Measure:Hours per day elapsed in the off state Timepoints:36 weeks ; Outcome name:the on time is defined as the time during which the medication is acting and, therefore, the symptoms of Parkinsons disease improve or are absent. Measure:Waking hours per day spent in the on state Timepoints:36 weeks ; Outcome name:the on time is defined as the time during which the medication is acting and, therefore, the symptoms of Parkinsons disease improve or are absent. Measure:Hours per day elapsed in the on state with no dyskinesia Timepoints:Week 36 ; Outcome name:Annoying dyskinesias are those that limit function or cause significant discomfort. the on time is defined as the time during which the medication is acting and, therefore, the symptoms of Parkinsons disease improve or are absent. Measure:Hours per day elapsed in the on state with annoying dyskinesias Timepoints:week 36 ; Outcome name:Annoying dyskinesias are those that limit function or cause significant discomfort. the on time is defined as the time during which the medication is acting and, therefore, the symptoms of Parkinsons disease improve or are absent. Measure:Hours per day elapsed in the on state without annoying dyskinesias Timepoints:week 36 ; Outcome name:Annoying dyskinesias are those that limit function or cause significant discomfort. Measure:Absolute duration of dyskinesias Timepoints:week 36 ; Outcome name:Hours per day elapsed in total sleep time. Measure:Hours per day elapsed in total sleep time. Timepoints:week 36 | — |
Countries
France, Peru, Spain
Contacts
Public ContactALFREDO PAREDES
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed