A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease (NCT06722729) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease
Japan150 participantsStarted 2024-12-16
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period