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A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease

NCT ID: NCT06722729

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-04-30

Brief Summary

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This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks in patients with advanced PD with levodopa.

Detailed Description

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This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered once daily in patients with advanced PD with levodopa.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KDT-3594

KDT-3594 capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks.

Group Type EXPERIMENTAL

KDT-3594

Intervention Type DRUG

Oral administration

Placebo

Placebo capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration

Interventions

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KDT-3594

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with PD according to the Parkinson's disease society brain bank clinical diagnostic criteria of the UK Parkinson's Disease Society
* Patients who are being treated with levodopa or levodopa combination drugs and have any of the following troublesome symptoms or conditions:
* Patients with wearing-off phenomenon
* Patients with ON-/OFF-phenomenon
* Patients with no-on/delayed on phenomenon
* Patients with inadequate response to levodopa

Exclusion Criteria

* Patients suspected of having parkinsonism other than PD based on medical history, physical findings, laboratory test values, dopamine transporter-single photon emission computed tomography (DAT-SPECT), etc.
* Patients who have undergone neurosurgical therapy for PD (e.g., stereotactic thalamotomy and pallidotomy and deep brain stimulation) or who are scheduled to undergo surgical therapy during the trial period
* Patients complicated with overt dementia or a Mini-Mental State Examination (MMSE) score of \< 24 at the start of the screening period
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoshitaka Shimizu

Role: STUDY_DIRECTOR

Kissei Pharmaceutical Co., Ltd.

Locations

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Research Site

Multiple Locations, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yoshitaka Shimizu

Role: CONTACT

Phone: Email only

Email: [email protected]

Other Identifiers

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Under registration

Identifier Type: REGISTRY

Identifier Source: secondary_id

KDT1203

Identifier Type: -

Identifier Source: org_study_id