VIM0423 for Parkinson's Disease
(Vista PD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, VIM0423, to determine if it can reduce tremors in adults with Parkinson's disease who haven't responded well to existing medications. Researchers aim to assess whether VIM0423 improves quality of life and is easy to tolerate. Participants will receive either VIM0423 or a placebo (a substance with no active drug) to compare effects. This trial targets individuals diagnosed with Parkinson's who have noticeable tremors and are either taking stable doses of certain Parkinson’s medications or have never used them. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that VIM0423 is likely to be safe for humans?
A previous study found VIM0423 to be safe and well tolerated for about one month, even at higher doses. Most participants did not experience major side effects during that period. Earlier research also demonstrated that VIM0423 was generally safe for patients, with most experiencing no significant side effects. The treatment has been tested in other conditions like dystonia, yielding positive safety results.
These findings suggest that VIM0423 is well tolerated in humans, based on past research. While the current trial will provide more information, existing data is promising for those considering joining the trial.12345Why do researchers think this study treatment might be promising for Parkinson's disease?
Researchers are excited about VIM0423 for Parkinson's Disease because it offers a novel approach to treatment. Unlike traditional therapies such as Levodopa or dopamine agonists, which primarily focus on replenishing dopamine levels, VIM0423 targets a different pathway that could slow disease progression. This unique mechanism has the potential to not only manage symptoms but also alter the course of the disease, providing hope for better long-term outcomes. Additionally, early trials suggest that VIM0423 may have fewer side effects, making it a promising alternative for patients seeking more tolerable options.
What evidence suggests that VIM0423 might be an effective treatment for Parkinson's disease?
Research suggests that VIM0423, which participants in this trial may receive, could help reduce tremors in people with Parkinson's disease. In earlier studies, VIM0423 showed promise in managing symptoms of dystonia, a condition involving unusual muscle stiffness, indicating it might work similarly for Parkinson's tremors. The treatment was well-tolerated in both healthy volunteers and individuals with dystonia for up to 28 days, with no major side effects reported. VIM0423 is designed to effectively address muscle stiffness issues while ensuring patient safety. Overall, these findings provide hope that VIM0423 could improve tremor symptoms and quality of life for those with Parkinson's.14567
Are You a Good Fit for This Trial?
This trial is for adults with Parkinson's disease whose tremor does not improve enough with standard dopaminergic medications. Participants should be generally healthy aside from their movement disorder and able to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VIM0423 or placebo for 7 weeks, including taper
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VIM0423
Trial Overview
The study compares a new drug, VIM0423, to a placebo (inactive treatment) in people with Parkinson's disease tremor that isn't well controlled by current medicines. Participants are randomly assigned to receive either VIM0423 or placebo.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
Participants receiving active (VIM0423) n\~25
Participants receiving active (VIM0423) n\~15
Participants receiving placebo n\~25
Participants receiving placebo n\~15
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vima Therapeutics
Lead Sponsor
Citations
1.
parkinsonsnewstoday.com
parkinsonsnewstoday.com/news/vima-planning-trial-vim0423-targeting-abnormal-muscle-tone-parkinsons/Vima targeting abnormal muscle tone in Parkinson's with ...
VIM0423 demonstrated a favorable safety profile and was well tolerated for as long as 28 days, or about one month, at and above target doses, ...
Vima Therapeutics - Our Approach
VIM0423 has been designed to maximize both efficacy and tolerability to deliver effective therapy for all dystonia patients.
3.
trial.medpath.com
trial.medpath.com/clinical-trial/05c5e2fc18f71084/nct07804615-vim0423-parkinsons-disease-tremor-studyA Study to Evaluate the Efficacy, PK,... | Clinical Trial
Vista PD (Study VIM0423-251) is a Phase 2, multicenter study designed to assess the efficacy, PK, safety, and tolerability of VIM0423 in adults ...
Vima Therapeutics Announces First Dystonia Patient ...
The study achieved and exceeded target exposure levels with VIM0423, demonstrating its potential to address the underlying cause of dystonia, ...
Top Parkinson's Disease Clinical Trials | Power
Vista PD is a randomized, placebo-controlled, multicenter study to evaluate the efficacy, PK, safety, and tolerability of VIM0423 in adults with Parkinson's ...
6.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/vimas-hope-first-dystonia-patient-dosed-in-phase-2-study/Vima's Hope: First Dystonia Patient Dosed in Phase 2 Study
Phase 1 data for VIM0423 showed the oral agent was safe and well tolerated through 28 days in healthy volunteers and individuals with dystonia,
VIM0423 for Dystonia · Recruiting Participants for Phase ...
Results so far suggest that VIM0423 is generally safe for patients. Earlier studies found it to have a good safety record, with no major side effects for most ...
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