KCT0004536尚未招募未知
A clinical study to determine the optimal dose of WIN-1001X by evaluating its efficacy and safety in patients with early Parkinson’s disease: double-blind, randomized, placebo-controlled, multicenter, phase II study
Medihelpline0 个研究点目标入组 188 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 30(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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