RecruitingPhase 2NCT06329141

A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients

A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Phase 2a Clinical Trial to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients


Sponsor

Glaceum

Enrollment

90 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

1. Study Objective \- To assess the efficacy and safety of vutiglabridin in early Parkindson's disease patients 2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in early Parkinson's disease patients. 3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 24 weeks according to the study protocol. Several parameters (i.e., MDS-UPDRS, CGI-C, K-NMSS, modified Hoehn-Yahr stage and SNBR) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called vutiglabridin can slow the progression of Parkinson's disease in the early stages. Vutiglabridin is designed to protect neurons (brain cells) by targeting a protein involved in energy metabolism. The goal is to preserve motor and cognitive function longer than current treatments allow. **You may be eligible if...** - You are between 40 and 75 years old - You were diagnosed with Parkinson's disease within the last 24 months - Your diagnosis was confirmed using standard clinical criteria and a brain scan (18F-FP-CIT PET) showing reduced dopamine transporter activity - Your Parkinson's is relatively mild (Hoehn-Yahr stage 2 or less) - You can walk and communicate independently (with or without an aid) **You may NOT be eligible if...** - You were diagnosed with Parkinson's more than 24 months ago - You have atypical Parkinsonism (e.g., MSA or PSP) - You have significant cognitive decline or major psychiatric illness - You are pregnant or trying to become pregnant - You have severe heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVutiglabridin

Once-daily oral administration

DRUGPlacebo

Once-daily oral administration


Locations(9)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

The Catholic University of Korea Uijeongbu St.Marys Hostpial

Uijeongbu-si, Gyeonggi-do, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Inje University Sanggye Paik Hospital

Seoul, South Korea

KyungHee University Medical Center

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06329141


Related Trials