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

Kissei

Status and phase: Enrolling; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: KDT-3594; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06722729

KDT1203

Under registration (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

KDT-3594

Experimental group

Description:

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

Treatment:

Drug: KDT-3594

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo