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

NCT04220762 | Unknown Phase 2

• 1 other identifier: WIN-1001X-P2
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change in MDS UPDRS Part Ⅲ

  Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).

  From baseline (0d) after administration of the investigational product for 12 weeks

Secondary Outcomes (8)

• Change in the MDS UPDRS Part Ⅲ

  After administration of the investigational product for 4 and 8 weeks

• Change in the MDS UPDRS Part Ⅰ

  After administration of the investigational product for 4, 8, and 12 weeks

• Change in the MDS UPDRS Part Ⅱ

  After administration of the investigational product for 4, 8, and 12 weeks

• Change in the MDS UPDRS Part Ⅰ+Part Ⅱ+Part Ⅲ

  After administration of the investigational product for 4, 8, and 12 weeks

• Change in the Modified Hoehn and Yahr scale

  After administration of the investigational product for 4, 8, and 12 weeks

Study Arms (4)

Test Group 1

EXPERIMENTAL

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.

Drug: WIN-1001X

Test Group 2

EXPERIMENTAL

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.

Drug: WIN-1001X

Test Group 3

EXPERIMENTAL

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.

Drug: WIN-1001X

Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

WIN-1001X 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 1; Test Group 2; Test Group 3

Placebo 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

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medi Help Line: lead

Study Sites (1)

Yeouido St.Mary's Hospital

Yeongdeungpo-dong, Seoul, 04537, South Korea

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ok Nam Park

  Medihelpline Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Joong-Seok Kim

CONTACT

+82-1588-1511; neuronet@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 7, 2020
• Study Start: January 21, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

KR (1)