A clinical study to determine the optimal dose of WIN-1001X by evaluating its efficacy and safety in patients with early Parkinson’s disease
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0004536
- Lead Sponsor
- Medihelpline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 188
1) Subjects =30 years old at the time of informed consent
2) 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.)
3) Modified Hoehn and Yahr stage = 3.0
4) K-MMSE (Korean Mini-Mental State Examination) score =20 at the screening visit (visit 1)
5) Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study
6) MDS UPDRS Part ?+Part ? score =18 at baseline (visit 2)
7) Subjects who have voluntarily determined to participate in this study and signed the written informed consent form
1) Atypical or secondary parkinsonism or benign tremulous parkinsonism
2) 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)
3) In case the investigators determine the symptom control is difficult with placebo
4) Hypersensitivity to herbal medicine
5) Subjects with dementia whose K-MMSE score is =19, severe psychopathy requiring treatment or hallucination
6) Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs
7) Clinically significant heart disease
8) Clinically significant hepatic insufficiency (in case of total bilirubin >2.0 mg/dL, or ALT and/or AST >2 times of upper limit of normal)
9) Clinically significant renal insufficiency (serum
creatinine =3.0 mg/dL)
10) History of surgical treatment for Parkinson’s disease
11) Glaucoma
12) Malignant tumor
13) Subjects who have been administered another investigational
product within 30 days prior to screening
14) 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)
15) History of chronic alcohol or drug abuse within last 6 months
16) Subjects who are otherwise considered to be ineligible for
this study on investigators’ judgment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in MDS UPDRS Part ?
- Secondary Outcome Measures
Name Time Method Change in the MDS UPDRS Part ?;Change in the MDS UPDRS Part ?;Change in the MDS UPDRS Part ?+Part ?+Part ?;Change in the Modified Hoehn and Yahr scale;Changes in each and total scores of 9 domains of the K-NMSS;Change in the K-MoCA;Changes in the summary index and total scores of the K-PDQ-39;Change in the K-MADRS;Changes in each and total scores of 8 domains of the K-SCOPA-AUT;Change in the Schwab and England ADL Scale;CGI-I score;Change in the MDS UPDRS Part ?