Parkinson's disease
Conditions
Interventions
During the up-titration period defined as the 5-week period from the start of the treatment period (Visit 2) to Week 5 (Visit 7), placebo or KDT-3594 will be administered at escalating doses ranging f
Sponsors
Shimizu Yoshitaka
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score - Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score - Response rate in the MDS-UPDRS Part III (ON-time) total score - Change from baseline in the proportion of OFF-time in awake time - Incidence of adverse events and treatment-related adverse events - Changes from baseline in clinical laboratory parameters (hematology, blood chemistry, and urinalysis) - Changes from baseline in vital signs (blood pressure, pulse rate, and temperature) and weight | — |
Contacts
Public ContactYoshitaka Shimizu
Kissei Pharmaceutical Co., Ltd.
Outcome results
None listed