Dyskinesia in Parkinson s Disease (Study P04501)

Not Applicable

• Conditions: -G20 Parkinson´s disease; Parkinson´s disease; G20

• Registration Number: PER-093-06
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Subjects must be ≥ 30 years of age, of any sex, and of any race, and have a diagnosis of moderate to severe idiopathic Parkinson´s disease for at least 5 years.
2. The subjects must have been in treatment with L-Dopa for at least 2 years.
3. The subjects must have been considered with a range of 3 to 4 in the off state.
4. The subjects must have been on a stable regimen of L-Dopa and a dopamine agonist for at least 4 weeks before selection, and must be experiencing motor fluctuations and dyskinesias on / off.
5. During the start period, subjects must demonstrate a minimum of 2 hours of off time during wakefulness per day for 3 consecutive days.
6. Women of childbearing age must have a negative pregnancy test in the selection. If the person is in the post-menopausal period, it must be at least 2 years after menopause before he or she can enter the study. Otherwise, the patient must use an appropriate method for birth control.
7. Clinical laboratory tests of subjects must be within normal or clinically acceptable limits for the researcher / sponsor.

Exclusion Criteria

1. Subjects presenting any form of atypical or drug-induced parkinsonism, cognitive impairment, a history of major depressive episode, mild unstable depression or psychosis, or subjects taking tolcapone will be excluded from the study.
2. Subjects with values ​​greater than those of the ULN in the selection for any of the following LFTs: ALT, AST, GGT, ALK-P, or T-BIL.
3. All subjects with a severe or ongoing unstable medical condition will be excluded.
4. Subjects with hepatic dysfunction confirmed serologically.
5. High blood pressure (BP).
6. Subjects who have received some prohibited treatment.
7. Women who are breastfeeding or those who are considering doing so are excluded from this study.
8. Subjects with allergy / sensitivity to the study drug or to their
excipients
9. Subjects with any clinically significant condition or situation, other than the condition being studied.
10. Subjects who have used any other investigational drug within 4 weeks of selection.
11. Subjects who are participating in some other clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified