A late phase II clinical trial of KDT-3594 in patients with Parkinson's disease

JRCT ID: jRCT2051240199

Registered date:27/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 01/12/2024
• Target sample size: 150
• Study type: Interventional

Intervention(s)

<Up-titration period>
During the up-titration period defined as the 5-week period from the start of the treatment period (Visit 2) to Week 5 (Visit 7), placebo or KDT-3594 will be administered at escalating doses ranging from 0.25 to 2 mg per day.
<Maintenance period>
During the maintenance period defined as the 12-week period from Week 5 (Visit 7) to Week 17 (Visit 10) of the treatment period, the dose fixed at Week 5 (Visit 7) of the treatment period will be administered as the maintenance dose.
<Down-titration period>
During the down-titration period defined as the period after the end of the treatment period, placebo or KDT-3594 will be administered once daily after breakfast for up to 6 days at tapering doses.

Outcome(s)

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

Secondary Outcome

<Efficacy Endpoints>
- Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score
- Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score
- Response rate in the MDS-UPDRS Part III (ON-time) total score
- Change from baseline in the proportion of OFF-time in awake time
<Safety Endpoints>
- Incidence of adverse events and treatment-related adverse events
- Changes from baseline in clinical laboratory parameters (hematology, blood chemistry, and urinalysis)
- Changes from baseline in vital signs (blood pressure, pulse rate, and temperature) and weight

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shimizu Yoshitaka