Phase II clinical study of OP-2024 in advanced Parkinson's disease

OHARA Pharmaceutical Co., Ltd.0 个研究点目标入组 12 人开始时间: 2023年11月29日最近更新: 2024年11月7日

适应症

试验速览

暂无简介。

•Patients who understand the informed consent form and have provided written consent.
•Patients diagnosed with "clinically established Parkinson's disease" according to MDS criteria.
•Patients with modified Hoehn and Yahr stages I-IV in ON state.
•Patients treated with approval levodopa/carbidopa hydrate tablets at screening (total daily dose of levodopa >=300 mg, four times per day).
•Patients with an estimated OFF time of >= 2.5 hours per day at screening.
•Patients with Mini mental state examination (MMSE) score >= 24 at screening.

•Patients diagnosed with nonideopathic Parkinson's disease.
•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.
•Patients who received any unapproved drug within 12 weeks or 5 times the half-life, whichever is longer, prior to screening.
•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
•Patients with or at risk of having angle closure glaucoma.

Safety

未报告次要终点

发起方