Phase 2a Study of VTX3232 in Parkinson's Disease

Launched by ZOMAGEN BIOSCIENCES LTD. · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a medication called VTX3232 to see if it is safe for people with early-stage idiopathic Parkinson's Disease (PD). The study will include around 10 participants between the ages of 40 and 80 who have been diagnosed with PD within the last five years and have stable symptoms. To qualify, participants should not have significant other brain conditions or have had brain surgery.

The trial will last about six weeks and involves several stages. First, there will be a 30-day period to check if participants meet the eligibility criteria. Then, participants will take VTX3232 for 28 days, followed by a 14-day follow-up period to monitor their health. This study is currently recruiting participants, and they will be closely observed throughout to ensure their safety while taking the medication. If you or someone you know is interested, it’s important to discuss eligibility and any questions with a healthcare provider.

Gender

ALL

Eligibility criteria

• 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.