TERMINATED

A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease. The study includes a screening period, a 28-day double-blind treatment period, and a 7-day follow-up period after last dose. Approximately 30 patients will be randomized into 1 of the 2 treatment arms.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

Quick Facts

Study Start:2025-03-05
Study Completion:2025-10-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06822517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 45 to 90 years of age, inclusive.
  2. * Body weight and body mass index (BMI) within the range of 100 to 265 pounds (45 to 120 kg) and 18 to 34 kg/m2 (inclusive), respectively.
  3. * A diagnosis of idiopathic PD according to United Kingdom (UK) Brain Bank or Movement Disorder Society (MDS) criteria with bradykinesia and ≥ 1 additional cardinal sign of PD (e.g., resting tremor, rigidity).
  4. * A diagnosis of PD for ≤ 7 years at Screening.
  5. * A modified Hoehn \& Yahr stage 1 to 2.5.
  6. * If presently receiving treatment for PD, must be on a stable dose for ≥ 2 weeks prior to dosing, with no expected change in this regimen for the duration of the study.
  7. * If presently taking any non-PD concomitant medications, must be on a stable dose for ≥ 2 weeks prior to dosing.
  1. * Any clinically significant abnormality at Screening
  2. * A positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV) 1/2 at Screening.
  3. * A significant neurological disease affecting the central nervous system, other than PD, that may affect cognition or ability to complete the study, including but not limited to dementias, severe and repetitive past (up to 5 years) head trauma, normal pressure hydrocephalus, or epilepsy or recurrent seizures (except febrile childhood seizures), as determined by the investigator.
  4. * Current serious or unstable illnesses, that, in the investigator's opinion, could compromise patient safety and ability to comply with study procedures, or has a life expectancy of \< 24 months.
  5. * A history of suicidal ideation or previous suicide attempt in the 12 months prior to Screening or is clinically judged by the investigator to be at serious risk for suicide as assessed by medical history, examination, or the C-SSRS.
  6. * A contraindication (e.g., current use of anticoagulants) that would prohibit a lumbar puncture (LP).
  7. * Currently enrolled in any other interventional clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study, as assessed by the investigator.
  8. * Has participated in a clinical trial involving an investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing.
  9. * Has levodopa-induced dyskinesias lasting for \> 25% of waking day or dyskinesias interfering with many daily activities.
  10. * Has dysphagia to the extent that it would affect the patient's ability to swallow the investigational medicinal product (IMP).
  11. * Has a parkinsonian syndrome, including atypical parkinsonism.
  12. * Is a known carrier (i.e., confirmed by historical medical documentation) of familial PD genes.

Contacts and Locations

Study Locations (Sites)

Investigative Site
Fountain Valley, California, 92708
United States
Investigative Site
San Jose, California, 95124
United States
Investigative Site
West Hills, California, 91307
United States
Investigative Site
Englewood, Colorado, 80113
United States
Investigative Site
Aventura, Florida, 33180
United States
Investigative Site
Boca Raton, Florida, 33486
United States
Investigative Site
Coral Gables, Florida, 33134
United States
Investigative Site
Coral Springs, Florida, 33067
United States
Investigative Site
Cutler Bay, Florida, 33189
United States
Investigative Site
Daytona Beach, Florida, 32117
United States
Investigative Site
Doral, Florida, 33178
United States
Investigative Site
Jacksonville, Florida, 32256
United States
Investigative Site
Maitland, Florida, 32751
United States
Investigative Site
Miami, Florida, 33135
United States
Investigative Site
Miami, Florida, 33165
United States
Investigative Site
Winter Park, Florida, 32789
United States
Investigative Site
Scarborough, Maine, 04074
United States
Investigative Site
Farmington Hills, Michigan, 48334
United States
Investigative Site
Abington, Pennsylvania, 19001
United States
Investigative Site
Memphis, Tennessee, 38157
United States
Investigative Site
Cypress, Texas, 77429
United States
Investigative Site
Round Rock, Texas, 78681
United States
Investigative Site
Spokane, Washington, 99202
United States

Collaborators and Investigators

Sponsor: Ventus Therapeutics U.S., Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05
Study Completion Date2025-10-09

Study Record Updates

Study Start Date2025-03-05
Study Completion Date2025-10-09

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease