Parkinson's disease
Conditions
Interventions
Subjects receive OP-2024-C or levodopa/carbidopa hydrate tablets single or multiple oral doses.
Sponsors
Taguchi Fumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who understand the informed consent form and have provided written consent. 2)Patients diagnosed with "clinically established Parkinson's disease" according to MDS criteria. 3)Patients with modified Hoehn and Yahr stages I-IV in ON state. 4)Patients treated with approval levodopa/carbidopa hydrate tablets at screening (total daily dose of levodopa >=300 mg, four times per day). 5)Patients with an estimated OFF time of >= 2.5 hours per day at screening. 6)Patients with Mini mental state examination (MMSE) score >= 24 at screening.
Exclusion criteria
Exclusion criteria: 1)Patients diagnosed with nonideopathic Parkinson's disease. 2) Patients who received deep brain stimulation (DBS), Stereotactic surgery, levodopa/carbidopa hydrate enteral combination solution or foslevodopa/foscarbidopa hydrate combination subcutaneous infusion for Parkinson's disease. 3)Patients who received any unapproved drug within 12 weeks or 5 times the half-life, whichever is longer, prior to screening. 4)Patients 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), COMT inhibitors, benserazide hydrochloride, apomorphine, alpha-methyldopa, reserpine, tetrabenazine, non-selective MAO inhibitors, iron preparations 5) Patients with or at risk of having angle closure glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, Efficacy | — |
Contacts
Public ContactDepartment of Clinical Development
OHARA Pharmaceutical Co.,Ltd.
Outcome results
None listed