NCT04867551

Brief Summary

Objective of this study is to investigate the safety, pharmacokinetics and efficacy of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 parkinson-disease

Timeline
Completed

Started May 2021

Shorter than P25 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
Last Updated

May 11, 2022

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

April 27, 2021

Last Update Submit

May 10, 2022

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • Occurrence of adverse events

    The numbers of events and subjects, the incidence regarding adverse events.

    8 weeks

  • Plasma concentrations of KDT-3594 and its metabolites

    Plasma concentrations of KDT-3594 and its metabolites during treatment period.

    8 weeks

Secondary Outcomes (1)

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    8 weeks

Study Arms (1)

KDT-3594

EXPERIMENTAL
Drug: KDT-3594

Interventions

KDT-3594DRUG

oral administration, dose titration

KDT-3594

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese patients
  • Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
  • Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale

You may not qualify if:

  • Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease.
  • Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
  • Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score \< 24 points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Yoshitaka Shimizu

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

May 15, 2021

Primary Completion

September 6, 2021

Study Completion

September 6, 2021

Last Updated

May 11, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)