A clinical study of KDT-3594 in Japanese patients with early Parkinson's disease.

JRCT ID: jRCT2031210089

Registered date:13/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 15/05/2021
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Oral and titrated doses of KDT-3594

Outcome(s)

Primary Outcome

-Occurrence of adverse events
-Plasma concentrations of KDT-3594 and its metabolites

• Secondary Outcome: -Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

-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

Exclude criteria

-Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease.
-Patients who underwent neurosurgical medical 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 Information

• Primary Sponsor: Shimizu Yoshitaka
• Secondary ID(s): NCT04867551