Parkinson's disease
Conditions
Interventions
Subjects receive OP-2024 or levodopa/carbidopa hydrate tablets multiple oral doses.
D012646
Sponsors
Hashimoto Hideaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Able to understand and provide written informed consent. 2) Subjects with a "clinically confirmed Parkinson's Disease" on the MDS clinical diagnostic criteria for Parkinson's disease. 3) Subjects with modified Hoehn and Yahr stages I-III in ON state. 4) Subjects treated with approval levodopa/carbidopa hydrate tablets at screening (total daily dose of levodopa >=300 mg, at least four times per day). 5) Subjects with OFF time of >= 2.5 hours per day at screening. 6) Patients with a Mini mental state examination (MMSE) score >= 24 at screening.
Exclusion criteria
Exclusion criteria: 1) Subjects diagnosed with nonideopathic Parkinson's disease. 2) Subjects who received deep brain stimulation (DBS), Stereotactic surgery, levodopa/carbidopa hydrate enteral combination solution or for Parkinson's disease. 3) Subjects who received any unapproved drug within 12 weeks prior to screening. 4) Subjects who received the following drugs 4 weeks prior to screening, or who are expected to receive the following drugs during the study period. levodopa (single agent), foslevodopa/foscarbidopa hydrate combination subcutaneous infusion, benserazide hydrochloride, Levodopa/Carbidopa/Entacapone combination tablet, apomorphine, alpha-methyldopa, reserpine, tetrabenazine, non-selective MAO inhibitors, iron preparations 5) Subjects with or at risk of having angle closure glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy (OFF time base on patients dairy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Safety | — |
Contacts
Public ContactDepartment of Clinical Development
OHARA Pharmaceuitical Co., Ltd
Outcome results
None listed