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Completed

NCT Number: NCT03845387

A 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KDT-3594

Drug

oral administration, dose titration

Pramipexole

Drug

ER formulation, oral administration, dose titration

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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