80 Participants NeededMy employer runs this trial

VIM0423 for Parkinson's Disease

(Vista PD Trial)

Recruiting at 29 trial locations
SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vima Therapeutics
Must be taking: Levodopa, Dopamine agonists
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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

My tremor meets the required baseline score for this study.
I have never taken levodopa or dopamine agonists for my condition.
I have been diagnosed with Parkinson's disease that includes tremor.
See 2 more

Exclusion Criteria

I am currently taking anticholinergic medication.
I have had brain surgery or procedures like DBS or thalamotomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks
2 visits (in-person)

Treatment

Participants receive VIM0423 or placebo for 7 weeks, including taper

7 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

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

Group I: Cohort 1Active Control1 Intervention
Group II: Cohort 2Active Control1 Intervention
Group III: Cohort 1 PlaceboPlacebo Group1 Intervention
Group IV: Cohort 2 PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vima Therapeutics

Lead Sponsor

Citations

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.

A 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 ...

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 ...