Actively Recruiting
A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients
Led by Glaceum · Updated on 2025-02-24
90
Participants Needed
9
Research Sites
99 weeks
Total Duration
On this page
Sponsors
G
Glaceum
Lead Sponsor
T
The Catholic University of Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand, consent, and follow the trial protocol, including reporting adverse events
- Adults aged 40 to 75 years at screening
- Diagnosed with Parkinson's disease by UKPDS Brain Bank criteria and confirmed reduced dopamine transporter on 18F-FP-CIT PET imaging
- Parkinson's diagnosis made within the last 24 months
- Hoehn-Yahr stage 2 or less
- Females of childbearing potential must have a negative pregnancy test and be non-lactating, surgically sterile, or postmenopausal (defined by age and hormonal criteria)
You will not qualify if you...
- Significant new illness within 4 weeks before or during screening
- Global Deterioration Scale score 4 or higher
- Clinically significant depression with Korean Beck Depression Inventory II score over 18
- Body mass index under 18.5 kg/m2
- Abnormal liver or kidney function tests beyond specified limits
- History or suspicion of Parkinson-plus syndromes or tremor-dominant Parkinson's disease
- Neurological impairments or abnormal brain imaging
- Severe heart failure, recent stroke, seizures, recent myocardial infarction or unstable angina
- Prior surgery for Parkinson's disease or major brain surgery
- Malignant tumors diagnosed within 5 years (except certain treated cancers)
- Secondary Parkinsonism diagnoses
- Swallowing problems
- Significant dizziness or nausea
- Use of certain Parkinson's medications or steroids within specified time frames
- Use of medications affecting reproductive hormones within 6 months
- Known intolerance to PET scan or 18F-fluoropropyl-CIT
- History of organ transplantation
- Positive tests for hepatitis B, C, HIV, or syphilis
- Known allergies to investigational product ingredients
- Planned surgery during the trial that could affect participation
- Recent participation in other clinical trials
- Unwillingness to use contraception during and 90 days after the study
- History of alcohol or drug abuse within 2 years or positive drug tests, except under specific medical conditions
- Any other condition judged unsuitable by the investigator
- Participation in other studies that may affect safety or efficacy assessments
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea, 14068
Actively Recruiting
2
The Catholic University of Korea Uijeongbu St.Marys Hostpial
Uijeongbu-si, Gyeonggi-do, South Korea, 11765
Actively Recruiting
3
Inje University Busan Paik Hospital
Busan, South Korea, 47392
Actively Recruiting
4
Inje University Sanggye Paik Hospital
Seoul, South Korea, 01757
Actively Recruiting
5
KyungHee University Medical Center
Seoul, South Korea, 02447
Actively Recruiting
6
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
7
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
8
The Catholic University of Korea
Seoul, South Korea, 06591
Actively Recruiting
9
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
Research Team
S
Sohee Loh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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