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

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

Shimizu Yoshitaka

Kissei Pharmaceutical Co., Ltd.

3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan

rinsyousiken@pharm.kissei.co.jp

Shimizu Yoshitaka

Kissei Pharmaceutical Co., Ltd.

3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan

+81-3-5684-3533

rinsyousiken@pharm.kissei.co.jp

Not Recruiting

Dec. 01, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Parkinson's disease

<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.

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

<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

+81-6-6443-1261

Nov. 11, 2024

Yes

- The Individual Patient Data (IPD) are available upon reasonable request and with permission of Kissei Pharmaceutical Co., Ltd. - For a data sharing request for IPD, please contact Kissei Pharmaceutical at rinsyousiken@pharm.kissei.co.jp.

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