Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether levodopa/benserazide dispersible is effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Samsung Medical Center; SMG-SNU Boramae Medical Center
• Treatments: Benserazide; Benserazide, levodopa drug combination; Levodopa

Criteria

Inclusion Criteria:

• Male or female patients between 31 and 80 years

• Parkinson disease (PD) was diagnosed by United Kingdom Parkinson disease brain bank criteria

• Patients receiving stable Levodopa treatment at least 2 weeks prior to baseline visit

• Delayed ON was confirmed by a specialized PD diary that records change in motor symptoms 90 minute after the first morning dose. Delayed ON is defined as delay of more than 40 minutes after the first morning dose for resolution of OFF state or experience of no ON state at least 1 per week.

Exclusion Criteria:

• Existence of cognitive decline hard to participate in the clinical trial or K-Minimental Status Exam score 24 or less

• Any contraindication of blood sampling

• Subjects with clinically significant psychiatric illness

• Subjects with a cancer or severe medical illness

• Lactating, pregnant, or possible pregnant

• History of malignant melanoma

• Subjects with narrow-angle glaucoma

• Subjects with hypersensitivity to levodopa or benserazide

• Subjects treated with non-selective monoamine oxidase (MAO)-B inhibitors

• Subjects with peptic ulcer, colitis, or gastrointestinal disease