Overview
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.
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
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