Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT06722729

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

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Kissei Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Detailed description

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 once daily in patients with advanced PD with levodopa.

Conditions

Interventions

TypeNameDescription
DRUGKDT-3594Oral administration
DRUGPlaceboOral administration

Timeline

Start date
2024-12-16
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2024-12-09
Last updated
2026-03-03

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT06722729. Inclusion in this directory is not an endorsement.