Clinical trial NCT06722729: A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease
Official title: A Late Phase II Clinical Trial of KDT-3594 in Patients With Advanced Parkinson's Disease With Levodopa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period
timeFrame: Up to 17 weeks
Secondary outcomes:
measure: Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score
timeFrame: Up to 17 weeks
measure: Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score
timeFrame: Up to 17 weeks
measure: Response rate in the MDS-UPDRS Part III (ON-time) total score
timeFrame: Up to 17 weeks
measure: Change from baseline in the proportion of OFF-time in awake time
timeFrame: Up to 17 weeks
measure: Change from baseline in OFF-time
timeFrame: Up to 17 weeks
measure: Incidence of adverse events and treatment-related adverse events
timeFrame: Up to 17 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yoshitaka Shimizu
role: STUDY_DIRECTOR
References: