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

Kissei

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: KDT-3594; Drug: Pramipexole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03845387

KDT1201

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

KDT-3594

Experimental group

Treatment:

Drug: KDT-3594

Pramipexole

Other group

Description:

Reference drug

Treatment:

Drug: Pramipexole