Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT02769793
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2016-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over Trial
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Delayed ON is one of the motor complications of advanced PD patients that effect of anti-parkinsonian medication is delayed more than 40 minutes after intake. In the most severe cases, the effect does not appear even until next medication schedule, so called "No ON" status. It is important to manage delayed ON properly because it can interfere motor functions and quality of life of PD patients.
Levodopa/benserazide dispersible can be absorbed rapidly in the intestine, so theoretically it can break the poor response to conventional treatment of PD patients with delayed ON. However, this has not been proven by clinical trials till now.
Levodopa/benserazide dispersible can be absorbed rapidly in the intestine, so theoretically it can break the poor response to conventional treatment of PD patients with delayed ON. However, this has not been proven by clinical trials till now.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: