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A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease

NCT06722729 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-03

No results posted yet for this study

Summary

This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks in patients with advanced PD with levodopa.

Conditions

  • Parkinson Disease

Interventions

DRUG

Placebo

Oral administration

DRUG

KDT-3594

Oral administration

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshitaka Shimizu · Kissei Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Japan

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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 NCT06722729 on ClinicalTrials.gov