MedPath

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
  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.
Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
crossover assignment
Primary Outcome Measures
NameTimeMethod
-

Efficacy (OFF time base on patients dairy)

Secondary Outcome Measures
NameTimeMethod

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