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

  • Clinicaltrials.gov identifier

    NCT04867551

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 30, 2021

  • Last update posted

    August 27, 2021

Study Description

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.

  • Condition or Disease:Parkinson Disease
  • Intervention/Treatment: Drug: KDT-3594
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 6 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase II Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
  • Actual Study Start Date: May 2021
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: March 2022

Arms and interventions

Arm Intervention/treatment
Experimental: KDT-3594
Drug: KDT-3594
oral administration, dose titration

Outcome Measures

  • Primary Outcome Measures: 1. Occurrence of adverse events [ Time Frame: 8 weeks ]
    The numbers of events and subjects, the incidence regarding adverse events.
  • 2. Plasma concentrations of KDT-3594 and its metabolites [ Time Frame: 8 weeks ]
    Plasma concentrations of KDT-3594 and its metabolites during treatment period.
  • Secondary Outcome Measures: 1. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 8 weeks ]
    Change from baseline (Week 0) in MDS-UPDRS total score

Eligibility Criteria

  • Ages Eligible for Study: 20 to 79 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Locations

Japan
Research Site
Multiple Locations

Sponsors and Collaborators

Kissei Pharmaceutical Co., Ltd.

Investigators

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

More Information

  • Responsible Party: Kissei Pharmaceutical Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT04867551 History of Changes
  • Other Study ID Numbers: KDT1202A
  • First Posted: April 30, 2021 Key Record Dates
  • Last Update Posted: August 27, 2021
  • Last Verified: August 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Parkinson Disease
    Parkinsonian Disorders
    Basal Ganglia Diseases
    Brain Diseases
    Central Nervous System Diseases
    Nervous System Diseases
    Movement Disorders
    Synucleinopathies
    Neurodegenerative Diseases