COMPLETED

Phase 2a Study of VTX3232 in Parkinson's Disease

Conditions

Idiopathic Parkinson Disease VTX3232 Idiopathic Parkinson's Disease NLRP3 Inhibitor Zomagen

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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 is a study to understand if taking VTX3232 is safe in participants diagnosed with early stage idiopathic Parkinson's Disease (PD). Approximately 10 patients will take VTX3232 Dose A. The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 7-day Pre-Baseline Period, a 28-day Open Label Treatment period (a participant receives active Dose A), and a 14-day Follow-Up Period.

Official Title

A Phase 2a, Single Site, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTX3232 in Participants With Early-Stage Parkinson's Disease

Quick Facts

Study Start:2024-08-08

Study Completion:2025-04-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06556173

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:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must be ≥ 40 years up to 80 years of age, inclusive, at the time of signing the informed consent, with BMI \> 18.5 and \< 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. * Diagnosis of idiopathic Parkinson's Disease between 0 and 60 months prior to screening. * Score of 2 or less on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV at screening. * Have not received prior treatment with deep brain stimulation (DBS). * If receiving treatment with symptomatic PD therapies, treatment must be stable. Note: The Medical Monitor should be contacted with any questions regarding concomitant therapies. * A female participant is eligible if they are of nonchildbearing potential * A male participant sexually active with a woman of child bearing potential is eligible if they agree to use contraception/barrier and refrain from donating sperm during the study and for at least 90 days after the last dose	* Diagnosis of a Parkinsonian syndrome other than idiopathic Parkinson's Disease. * A diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease; history of repeated head injury or traumatic brain injury; history of epilepsy or seizure disorder other than febrile seizures as a child. * History of brain surgery.

Inclusion Criteria

Exclusion Criteria

* Participants must be ≥ 40 years up to 80 years of age, inclusive, at the time of signing the informed consent, with BMI \> 18.5 and \< 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
* Diagnosis of idiopathic Parkinson's Disease between 0 and 60 months prior to screening.
* Score of 2 or less on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV at screening.
* Have not received prior treatment with deep brain stimulation (DBS).
* If receiving treatment with symptomatic PD therapies, treatment must be stable. Note: The Medical Monitor should be contacted with any questions regarding concomitant therapies.
* A female participant is eligible if they are of nonchildbearing potential
* A male participant sexually active with a woman of child bearing potential is eligible if they agree to use contraception/barrier and refrain from donating sperm during the study and for at least 90 days after the last dose

* Diagnosis of a Parkinsonian syndrome other than idiopathic Parkinson's Disease.
* A diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease; history of repeated head injury or traumatic brain injury; history of epilepsy or seizure disorder other than febrile seizures as a child.
* History of brain surgery.

Contacts and Locations

Principal Investigator

Snehal Naik, PhD

STUDY_DIRECTOR

Zomagen Biosciences Ltd.

Study Locations (Sites)

Local Site #840001

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Zomagen Biosciences Ltd.

Snehal Naik, PhD, STUDY_DIRECTOR, Zomagen Biosciences Ltd.

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 Date2024-08-08

Study Completion Date2025-04-04

Study Record Updates

Study Start Date2024-08-08

Study Completion Date2025-04-04

Terms related to this study

Keywords Provided by Researchers

VTX3232
Idiopathic Parkinson's Disease
NLRP3 Inhibitor
Zomagen

Additional Relevant MeSH Terms

Idiopathic Parkinson Disease