Status:
COMPLETED
Phase 2a Study of VTX3232 in Parkinson's Disease
Lead Sponsor:
Zomagen Biosciences Ltd.
Conditions:
Idiopathic Parkinson Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06556173
Start Date
August 8 2024
End Date
April 4 2025
Last Update
July 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Site #840001
New Haven, Connecticut, United States, 06510