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A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD

NCT04821687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2023-06-01

No results posted yet for this study

Summary

A Study to evaluate the add-on efficacy and safety of opicapone 50 mg or an extra dose of L-DOPA 100 mg for the treatment of wearing-off in patients with PD.

Conditions

  • Parkinson Disease

Interventions

DRUG

Ongentys 50mg

Opicapone 50mg will be added to current and stable therapy of L-DOPA/DDCI

DRUG

Madopar Tab. 125 or Perkin Tab. 25-100mg

Madopar Tab. 125 or Perkin Tab. 25-100mg will be added to current and stable therapy of L-DOPA/DDCI

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2022-08-18
Completion
2022-08-18

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 NCT04821687 on ClinicalTrials.gov