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

Sponsor

Kissei Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03845387

Collaborator

(none)

Enrollment

Location

Arms

11.8

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 26, 2019

Actual Primary Completion Date :

Feb 21, 2020

Actual Study Completion Date :

Feb 21, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: KDT-3594

Drug: KDT-3594

oral administration, dose titration

Other: Pramipexole

Reference drug

Drug: Pramipexole

ER formulation, oral administration, dose titration

Outcome Measures

Primary Outcome Measures

Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score [12 weeks]
Change from baseline (Week 0) in MDS-UPDRS total score

Secondary Outcome Measures

Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score [12 weeks]
Change from baseline (Week 0) in PDQ-39 summary index score
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score [12 weeks]
Change from baseline (Week 0) in PDSS-2 total score

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Multiple Locations		Japan

Sponsors and Collaborators

Kissei Pharmaceutical Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kissei Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03845387

Other Study ID Numbers:

KDT1201

First Posted:

Feb 19, 2019

Last Update Posted:

Feb 17, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Pramipexole

Study Results

No Results Posted as of Feb 17, 2021