Phase 2a Study of VTX3232 in Parkinson's Disease
Completed · Phase 2
Conditions studied: Idiopathic Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT06556173
- Run by
- Zomagen Biosciences Ltd.
- People needed
- 11
- Starts
- 2024-08-08
- Expected to finish
- 2025-04-04
- Last updated by the study team
- 2026-04-15
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Local Site #840001 — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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