New pill hopes to slow Parkinson's in early stages

NCT ID NCT06329141

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tested a new drug called vutiglabridin in 99 people with early Parkinson's disease. Participants took either the drug or a placebo daily for 24 weeks. The goal was to see if the drug is safe and can help control symptoms like movement problems. The study is complete, but results are not yet reported.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

99 people

The number who actually took part.

Started

Jul 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to read, understand, and provide written consent for the trial, comply with the clinical trial protocol, and communicate any adverse events (AEs) and other clinically significant information to the investigator (able to complete the evaluation, including walking or using walking aids). 2. Adult men and women between the ages of 40 and 75 at Screening. 3. Diagnosed with Parkinson's disease according to the UK Parkinson's Disease Society (UKPDS) Brain Bank clinical diagnostic criteria and confirmed the reduction of dopamine transporter on 18F-FP-CIT PET imaging at Screening. 4. Diagnosed with Parkinson's disease within the last 24 months. 5. Hoehn-Yahr stage ≤ 2 6. Eligible females will be: * females of childbearing potential who are not pregnant, evidenced by a negative serum hCG pregnancy test at Screening * non-lactating, or * surgically sterile (defined as documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, hysterectomy) or postmenopausal. * Definition of menopause * 50 years or over: 12 or more consecutive months without menstruation, in the absence of other conditions. * Less than 50 years: FSH level is \> 40 IU/L and 12 or more consecutive months without menstruation, in the absence of other conditions. Exclusion Criteria: 1. Clinically significant new illness, per Investigator judgment, in the 4 weeks before Screening and during the screening period. 2. Global Deterioration Scale (GDS) ≥ 4 at Screening. 3. Have clinically significant depression as indicated by a Korean Beck Depression Inventory II score (K-BDI-II) \> 18 at Screening. 4. BMI less than 18.5 kg/m2 at Screening. 5. Have the following laboratory test results: * Clinically significant abnormal hepatic (i.e., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 2x ULN, unless documented Gilbert's syndrome) * Renal function laboratory test (i.e., GFR \< 60 mL/min). 6. Have the following medical history: * Diagnosed with or suspected to have \*Parkinson-plus syndromes (PPS) * PPS: Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Diffuse Lewy Body Disease, etc. * Tremor-dominant Parkinson's disease, per Investigator judgment. * Symptoms or signs indicative of neurological functional impairment or known abnormalities in brain CT or MRI imaging. * A history of severe heart failure (NYHA class III \~ IV), stroke, cerebral ischemic attacks, or seizures within the past year before screening; or those with a history of myocardial infarction or unstable angina within the last 6 months before screening. * Have undergone surgery for Parkinson's disease treatment (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation) or any other major brain surgery. * Diagnosed with malignant tumors within the past 5 years before screening (except for adequately treated basal cell carcinoma, cervical intraepithelial neoplasia, thyroid cancer, or flat epithelial atypia). * Diagnosed with secondary Parkinsonism (drug-induced Parkinsonism, normal pressure hydrocephalus, vascular Parkinsonism). 7. Have swallowing problems 8. Have clinically significant dizziness, nausea, per Investigator's judgment. 9. Currently taking any of the following medications and have the willingness and ability to continue taking them throughout the clinical trial period: * Within the 4 weeks before baseline, taking any Parkinson's disease medications, including dopamine agonists, dopamine-depleting enzyme inhibitors \[monoamine oxidase inhibitors (MAOi), COMT (catechol-O-methyltransferase) inhibitors\], non-dopaminergic drugs (anticholinergic agents, amantadine, etc.), and others PD medications (In case of irreversible MAO-B inhibitor, within the 90 days before baseline) * Within the 12 weeks before screening, have used systemic steroids continuously for 7 days or longer. * Within the 12 weeks before baseline, taking levodopa or levodopa combinations (including history of levodopa use for more than 4 weeks) * Currently taking medications known to be substrates of breast cancer resistant protein (BCRP) at screening (e.g., rosuvastatin, serpalan, etc.) (Note: If switched to another drug of the same class, the subject may be eligible for inclusion). * taking of any medication within 6 months of Screening that can alter reproductive hormone levels, either as the intended effect or as a side effect, including: anabolic steroids, androstenedione, bicalutamide, cimetidine, dehydroepiandrosterone, diethylstilbestrol, other estrogens, dutasteride, finasteride, glucocorticoids (e.g., prednisone, cortisone, hydrocortisone, and decadron), oral ketoconazole, megestrol acetate, opiates (e.g., morphine, codeine, oxycodone, hydrocodone), spironolactone, testosterone or any androgen, and any medications for treating prostate cancer. 10. Have taken of stable doses of levodopa or levodopa combination 11. Have known or suspected intolerance to PET scan or fluoropropyl-CIT (18F). 12. Have a history of organ transplantation. 13. Tested positive for HBsAg, HCV Ab, HIV Ag/Ab, or VDRL(RPR) antibodies in screening tests. 14. Known hypersensitivity or contraindication to the main ingredient and excipients of the investigational product. 15. Anticipated to undergo surgery during the clinical trial period or to receive surgical interventions that may affect the completion of the trial or compliance with the clinical trial protocol. 16. Participated in a clinical trial for an investigational drug or medical device for a period equal to or longer than five times the drug's half-life at baseline or within the past 12 weeks, whichever is longer. 17. Unwilling, or whose partner is unwilling, to use a medically acceptable means of \*contraception during and for 90 days following completion/withdrawal of the study. * Medically acceptable contraceptive methods include: * intrauterine device that has been proven highly effective, used by the subject or the subject's spouse/partner * physical contraception (male or female) used with chemical sterilization surgical sterilization of the subject or the subject's partner (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy * oral hormonal contraceptive used by the spouse/partner of male subject. 18. Within the last 2 years before screening or during the screening period, have a history of alcohol or drug abuse, or have tested positive for drug use during the screening period (Note: Subjects who have used drugs for the purpose of chronic pain treatment, have documented records of medical history and concomitant medications, may, at the investigator's discretion and with the sponsor's approval, be eligible for inclusion as trial subjects). 19. Deemed unsuitable for participation in the clinical trial by the investigator due to reasons including clinical laboratory test results and other factors. 20. Participating in a non-interventional clinical study that may affect the safety or efficacy assessment of subjects in this clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hallym University Medical Center

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • Inje University Sanggye Paik Hospital

    Seoul, 01757, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • KyungHee University Medical Center

    Seoul, 02447, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • The Catholic University of Korea

    Seoul, 06591, South Korea

  • The Catholic University of Korea Uijeongbu St.Marys Hostpial

    Uijeongbu-si, Gyeonggi-do, 11765, South Korea

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