At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 201 enrolled
Drug / intervention
Safinamide Mesilatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Patients With Motor Fluctuation in South Korea
In Brief
A Phase 4 clinical trial evaluating Safinamide Mesilate for Parkinson Disease. Completed, enrolled 201 participants across 20 sites.
Detailed Summary
The primary purpose of this study is to evaluate the change at the 18th week from baseline in daily "off" time measured by participant diary and Parkinson's Disease Questionnaire-39 (PDQ-39) in participants with Parkinson's Disease who are receiving levodopa.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartApr 2022
Primary CompletionMay 2023
TodayJul 2026
First PostedApr 5, 2022
Enrollment StartApr 5, 2022
Primary CompletionMay 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.2 years ago
Interventions
Safinamide Mesilatedrug
Safinamide Mesilate oral tablets.