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

NCT ID: NCT04220762

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2021-09-30

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test Group 1

The randomized patients are administered 3 tablets of the investigational product (400mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Group Type: EXPERIMENTAL

WIN-1001X

Intervention Type: DRUG

This study has been designed as a randomized, double-blind, and placebo-controlled study.

Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Test Group 2

The randomized patients are administered 3 tablets of the investigational product (800mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Group Type: EXPERIMENTAL

WIN-1001X

Intervention Type: DRUG

This study has been designed as a randomized, double-blind, and placebo-controlled study.

Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Test Group 3

The randomized patients are administered 3 tablets of the investigational product (1200mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Group Type: EXPERIMENTAL

WIN-1001X

Intervention Type: DRUG

This study has been designed as a randomized, double-blind, and placebo-controlled study.

Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Placebo group

The randomized patients are administered 3 tablets of the placebo drug twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This study has been designed as a randomized, double-blind, and placebo-controlled study.

Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Interventions

WIN-1001X

This study has been designed as a randomized, double-blind, and placebo-controlled study.

Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Intervention Type: DRUG

Placebo

This study has been designed as a randomized, double-blind, and placebo-controlled study.

Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medi Help Line

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ok Nam Park

Role: STUDY_DIRECTOR

Medihelpline Co., Ltd.

Locations

Yeouido St.Mary's Hospital

Yeongdeungpo-dong, Seoul, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Joong-Seok Kim

Role: CONTACT

neuronet@catholic.ac.kr

+82-1588-1511

Facility Contacts

Yoon-Sang Oh

Role: primary

Other Identifiers

WIN-1001X-P2

Identifier Type: -

Identifier Source: org_study_id