NCT03845387

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
Completed

Started Feb 2019

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

February 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

February 15, 2019

Last Update Submit

February 16, 2021

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

    Change from baseline (Week 0) in MDS-UPDRS total score

    12 weeks

Secondary Outcomes (2)

  • Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score

    12 weeks

  • Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score

    12 weeks

Study Arms (2)

KDT-3594

EXPERIMENTAL
Drug: KDT-3594

Pramipexole

OTHER

Reference drug

Drug: Pramipexole

Interventions

KDT-3594DRUG

oral administration, dose titration

KDT-3594
PramipexoleDRUG

ER formulation, oral administration, dose titration

Pramipexole

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

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Naomi Koshihara

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 19, 2019

Study Start

February 26, 2019

Primary Completion

February 21, 2020

Study Completion

February 21, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

JP(1)