NIPH Clinical Trials Search

OP-2024-004 study

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Parkinson's disease
Date of first enrollment	26/03/2025
Target sample size	168
Countries of recruitment
Study type	Interventional
Intervention(s)	Subjects receive OP-2024 or levodopa/carbidopa hydrate tablets multiple oral doses.

Outcome(s)

Primary Outcome	Efficacy (OFF time base on patients dairy)
Secondary Outcome	Efficacy, Safety

Key inclusion & exclusion criteria

Age minimum	>= 30age old
Age maximum	< 85age old
Gender	Both
Include 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.
Exclude 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.