Trials / Completed
CompletedNCT05312632
A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 201 (actual)
- Sponsor
- Eisai Korea Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Safinamide Mesilate | Safinamide Mesilate oral tablets. |
Timeline
- Start date
- 2022-04-05
- Primary completion
- 2023-05-25
- Completion
- 2023-05-25
- First posted
- 2022-04-05
- Last updated
- 2024-09-23
- Results posted
- 2024-09-23
Locations
20 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05312632. Inclusion in this directory is not an endorsement.