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Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease

NCT06596005 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2026-01-16

Study results available
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Summary

A randomized, double-blind, placebo parallel-controlled Phase II clinical trial to evaluate the efficacy and safety of TJ0113 capsule in patients with early-stage Parkinson's disease

Conditions

  • Parkinson Disease

Interventions

DRUG

TJ0113 200mg

200 mg Capsule, Once Daily

DRUG

TJ0113 400mg

400 mg Capsule, Once Daily

DRUG

Placebo

Capsule, Once Daily

Sponsors & Collaborators

  • Taizhou Hospital

    collaborator OTHER

  • Wenzhou Central Hospital

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Jiaxing University

    collaborator OTHER

  • Hangzhou PhecdaMed Co., Ltd.

    collaborator INDUSTRY

  • Huzhou Central Hospital

    collaborator OTHER

  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Wei Luo, Doctor · Sceond Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-18
Primary Completion
2025-09-03
Completion
2025-09-09

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06596005 on ClinicalTrials.gov