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VTX3232 for Parkinson's Disease
Phase 2
Recruiting
Research Sponsored by Zomagen Biosciences, Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be ≥ 40 years up to 80 years of age, inclusive, with BMI > 18.5 and < 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females
Score of 2 or less on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV at screening
Must not have
Diagnosis of a Parkinsonian syndrome other than idiopathic Parkinson's Disease
History of brain surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of treatment period to day 28 of treatment period
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether taking VTX3232 is safe for people with early-stage Parkinson's Disease. About 10 patients will be given Dose A of VTX3232. The study
Who is the study for?
This clinical trial is for about 10 people with early stage idiopathic Parkinson's Disease. Participants must pass a screening to qualify and will be involved in the study for around 79 days, including treatment and follow-up periods.
What is being tested?
The trial is testing the safety of a new medication called VTX3232 in patients with Parkinson's Disease. It includes several phases: screening, pre-baseline, a treatment period where participants receive the drug, and follow-up.
What are the potential side effects?
Since this summary doesn't provide specific side effects of VTX3232, it can be assumed that potential side effects will be monitored throughout the study as part of assessing the drug's safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 80 years old, with a healthy weight for my height.
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My Parkinson's symptoms are mild, scoring 2 or less on a specific scale.
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I have never had deep brain stimulation treatment.
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I am a woman who cannot become pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My condition is a type of Parkinsonian syndrome, not classic Parkinson's Disease.
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I have had brain surgery in the past.
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I do not have Parkinson's, but I have a significant brain condition or a history of serious head injuries or seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of treatment period to day 28 of treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of treatment period to day 28 of treatment period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion
Secondary study objectives
Pharmacokinetics (PK) of VTX3232 in plasma and Cerebrospinal Fluid (CSF) at Day 28
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VTX3232 Dose AExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Zomagen Biosciences, LtdLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Zomagen Biosciences Ltd.Lead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Snehal Naik, PhDStudy DirectorZomagen Biosciences Ltd.
2 Previous Clinical Trials
435 Total Patients Enrolled