Evaluating KDT-3594 for Parkinson's Disease
A Late Phase II Clinical Trial of KDT-3594 in Patients With Advanced Parkinson's Disease With Levodopa
PHASE2 · Kissei Pharmaceutical Co., Ltd. · NCT06722729
This study is testing a new medication called KDT-3594 to see if it can help people with advanced Parkinson's Disease who are already taking levodopa feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kissei Pharmaceutical Co., Ltd. (industry) |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06722729 on ClinicalTrials.gov |
What this trial studies
This late phase II clinical trial is designed to assess the efficacy, safety, and pharmacokinetics of KDT-3594 in patients with advanced Parkinson's Disease who are currently on levodopa treatment. The trial will be multicenter, randomized, double-blind, and placebo-controlled, involving escalating doses of KDT-3594 administered once daily for 17 weeks. Participants will be monitored for improvements in troublesome symptoms associated with their condition.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with Parkinson's Disease who are currently treated with levodopa and experience troublesome symptoms such as wearing-off or ON-/OFF-phenomena.
Not a fit: Patients with parkinsonism other than Parkinson's Disease or those who have undergone neurosurgical therapy for PD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of symptoms in patients with advanced Parkinson's Disease.
How similar studies have performed: Other studies have shown promise in similar approaches, but the specific efficacy of KDT-3594 remains to be established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Multiple Locations
- Research Site — Multiple Locations, Japan (RECRUITING)
Study contacts
- Study coordinator: Yoshitaka Shimizu
- Email: rinsyousiken@pharm.kissei.co.jp
- Phone: Email only
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease