A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

February 16, 2021 updated by: Kissei Pharmaceutical Co., Ltd.

A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Multiple Locations, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KDT-3594
oral administration, dose titration
Other: Pramipexole
Reference drug
ER formulation, oral administration, dose titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Time Frame: 12 weeks
Change from baseline (Week 0) in MDS-UPDRS total score
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score
Time Frame: 12 weeks
Change from baseline (Week 0) in PDQ-39 summary index score
12 weeks
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
Time Frame: 12 weeks
Change from baseline (Week 0) in PDSS-2 total score
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Naomi Koshihara, Kissei Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

February 21, 2020

Study Completion (Actual)

February 21, 2020

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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