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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

NCT05312632 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2024-09-23

Study results available
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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

  • Parkinson Disease

Interventions

DRUG

Safinamide Mesilate

Safinamide Mesilate oral tablets.

Sponsors & Collaborators

  • Eisai Korea Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2023-05-25
Completion
2023-05-25

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05312632 on ClinicalTrials.gov