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

NCT06722729 | Active Not Recruiting Phase 2

• 2 other identifiers: KDT1203Under registration
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period

  MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question, a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. In all parts, a higher score indicated more severe symptoms of PD, and the score range of each part are as follows. * Part I: 0-52 * Part II: 0-52 * Part III: 0-132 * Part IV: 0-24 * Total Score: 0-260 * Part II+III: 0-184 (MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (range 0-184)).

  Up to 17 weeks

Secondary Outcomes (6)

• Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score

  Up to 17 weeks

• Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score

  Up to 17 weeks

• Response rate in the MDS-UPDRS Part III (ON-time) total score

  Up to 17 weeks

• Change from baseline in the proportion of OFF-time in awake time

  Up to 17 weeks

• Change from baseline in OFF-time

  Up to 17 weeks

Study Arms (2)

KDT-3594

EXPERIMENTAL

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

Drug: KDT-3594

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KDT-3594 DRUG

Oral administration

KDT-3594

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kissei Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Research Site

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yoshitaka Shimizu

  Kissei Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 9, 2024
• Study Start: December 16, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)