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OpenTrials
Completed

NCT Number: NCT06556173

Phase 2a Study of VTX3232 in Parkinson's Disease

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Site #840001

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion criteria

  • 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.

Treatment and study plan

VTX3232

Drug

Dose A

Primary outcomes

  1. Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion

    Time frame: Day 1 of treatment period through study completion, up to 6 weeks

    Incidence of AEs and SAEs

Secondary outcomes

  1. Pharmacokinetics (PK) of VTX3232 in plasma and Cerebrospinal Fluid (CSF) at Day 28

    Time frame: Day 1 of treatment period to Day 28 of treatment period

    Concentration of VTX3232 in plasma and CSF through 28 days of study treatment

Sponsors and collaborators

Lead sponsor

Zomagen Biosciences Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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