Clinical trial NCT04220762: A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Medi Help Line
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 188
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objective of this study is to evaluate the difference in the change of MDS UPDRS Part Ⅲ between WIN-1001X 400 mg, 800 mg, and 1200 mg as the test drugs compared to placebo as the control drug after administering them for 12 weeks.

The secondary objectives of this study are to evaluate the therapeutic efficacy and safety of the 3 dose groups of WIN-1001X compared to placebo group by assessing the changes in MDS UPDRS Part Ⅲ after administering the investigational products for 4 and 8 weeks, the changes in MDS UPDRS Part Ⅰ, Part Ⅱ, Part Ⅰ+Part Ⅱ+Part Ⅲ, and Modified Hoehn and Yahr scale after administering for 4, 8, and 12 weeks, the changes in K-NMSS (Non-Motor Symptoms Scale), K-MoCA (Korean-Montreal Cognitive Assessment), K-PDQ-39 (Parkinson's Disease Questionnaire) score.

Eligibility 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

Primary outcomes:
measure: Change in MDS UPDRS Part Ⅲ
timeFrame: From baseline (0d) after administration of the investigational product for 12 weeks
Secondary outcomes:
measure: Change in the MDS UPDRS Part Ⅲ
timeFrame: After administration of the investigational product for 4 and 8 weeks
measure: Change in the MDS UPDRS Part Ⅰ
timeFrame: After administration of the investigational product for 4, 8, and 12 weeks
measure: Change in the MDS UPDRS Part Ⅱ
timeFrame: After administration of the investigational product for 4, 8, and 12 weeks
measure: Change in the MDS UPDRS Part Ⅰ+Part Ⅱ+Part Ⅲ
timeFrame: After administration of the investigational product for 4, 8, and 12 weeks
measure: Change in the Modified Hoehn and Yahr scale
timeFrame: After administration of the investigational product for 4, 8, and 12 weeks
measure: Changes in each and total scores of K-NMSS
timeFrame: After administration of the investigational product for 4 and 12 weeks
measure: Change in the K-MoCA
timeFrame: After administration of the investigational product for 4 and 12 weeks
measure: Changes in the summary index and total scores of the K-PDQ-39
timeFrame: After administration of the investigational product for 4 and 12 weeks
Other outcomes:
Locations:
city: Yeongdeungpo-dong
country: Korea, Republic of
facility: Yeouido St.Mary's Hospital
state: Seoul
Study officials:
affiliation: Medihelpline Co., Ltd.
name: Ok Nam Park
role: STUDY_DIRECTOR
References: