NCT06722729CompletedPhase 2
A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease
A Late Phase II Clinical Trial of KDT-3594 in Patients With Advanced Parkinson's Disease With Levodopa
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 178 (actual)
- First submitted
- 26 Nov 2024
- Start date
- 16 Dec 2024
- Primary completion date
- 14 Jan 2026
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT06722729
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 178
- From 16 Dec 2024 to the primary completion date, 14 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients complicated with overt dementia or a Mini-Mental State Examination (MMSE) score of \< 24 at the start of the screening period
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Tokyo and Other Japanese Cities | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.