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
Trial ID: NCT06556173
Interventional - Phase 2 - Completed
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.
Conditions
Idiopathic Parkinson Disease
Interventions
VTX3232
Eligibility
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.