A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the optimal dose of WIN-1001X for its therapeutic confirmatory study by comparing and evaluating the efficacy and safety of each dose group by conducting a therapeutic exploratory study on three dose groups of WIN-1001X 400 mg, 800 mg, and 1200 mg, and placebo group in patients with early Parkinson's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medi Help Line

Criteria

Inclusion Criteria:

• Subjects ≥30 years old at the time of informed consent

• Subjects diagnosed with Parkinson's disease satisfying the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹⁸F-FP-CIT PET, etc.)

• Modified Hoehn and Yahr stage ≤ 3.0

• K-MMSE (Korean Mini-Mental State Examination) score ≥20 at the screening visit (visit 1)

• Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study

• MDS UPDRS Part Ⅱ+Part Ⅲ score ≥18 at baseline (visit 2)

• Subjects who have voluntarily determined to participate in this study and signed the written informed consent form

Exclusion Criteria:

• Atypical or secondary parkinsonism or benign tremulous parkinsonism

• History of treatments with levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled)

• In case the investigators determine the symptom control is difficult with placebo

• Hypersensitivity to herbal medicine

• Subjects with dementia whose K-MMSE score is ≤19, severe psychopathy requiring treatment or hallucination

• Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs

• History of surgical treatment for Parkinson's disease

• Subjects who have been administered another investigational product within 30 days prior to screening

• Female subjects who are pregnant or lactating, or who have child-bearing potential (i.e., (i) those who are not surgically non-infertile, or (ii) who are not using adequate contraceptive methods [including at least one of the barrier methods], or (iii) who are not sexually abstinent, or (iv) for whom at least 2 years have not elapsed since their last menstruation)

• History of chronic alcohol or drug abuse within last 6 months

• Subjects who are otherwise considered to be ineligible for this study on investigators' judgment