OP-2024-004 study
Recruiting
- Conditions
- Parkinson's disease
- Registration Number
- jRCT2021240047
- Lead Sponsor
- OHARA Pharmaceuitical Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 168
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- crossover assignment
- Primary Outcome Measures
Name Time Method - Efficacy (OFF time base on patients dairy)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does OP-2024 target in advanced Parkinson's disease?
How does OP-2024 compare to standard-of-care therapies like levodopa in PD patients?
Which biomarkers are used for patient selection in the OHARA jRCT2021240047 trial?
What adverse events are associated with OP-2024 in Parkinson's disease treatment?
Are there combination therapies or competitor drugs similar to OP-2024 for Parkinson's disease?