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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845387
• Other study ID #: KDT1201
• Status: Completed
• Phase: Phase 2
• Start date: February 26, 2019
• Est. completion date: February 21, 2020

Study information

• Verified date: February 2021
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• KDT-3594
oral administration, dose titration
• Pramipexole
ER formulation, oral administration, dose titration

Locations

Country	Name	City	State
Japan	Research Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score	Change from baseline (Week 0) in PDQ-39 summary index score	12 weeks
Secondary	Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score	Change from baseline (Week 0) in PDSS-2 total score	12 weeks