Phase III clinical study of OP-2024 in patients with advanced Parkinson's disease

OHARA Pharmaceuitical Co., Ltd0 个研究点目标入组 168 人开始时间: 2025年3月26日最近更新: 2025年5月26日

适应症

试验速览

暂无简介。

•Able to understand and provide written informed consent.
•Subjects with a "clinically confirmed Parkinson's Disease" on the MDS clinical diagnostic criteria for Parkinson's disease.
•Subjects with modified Hoehn and Yahr stages I-III in ON state.
•Subjects treated with approval levodopa/carbidopa hydrate tablets at screening (total daily dose of levodopa >=300 mg, at least four times per day).
•Subjects with OFF time of >= 2.5 hours per day at screening.
•Patients with a Mini mental state examination (MMSE) score >= 24 at screening.

•Subjects diagnosed with nonideopathic Parkinson's disease.
•Subjects who received deep brain stimulation (DBS), Stereotactic surgery, levodopa/carbidopa hydrate enteral combination solution or for Parkinson's disease.
•Subjects who received any unapproved drug within 12 weeks prior to screening.
•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
•Subjects with or at risk of having angle closure glaucoma.

Efficacy (OFF time base on patients dairy)

未报告次要终点

发起方

OHARA Pharmaceuitical Co., Ltd