VIM0423 for Dystonia

Not yet recruiting at 8 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vima Therapeutics

Disqualifiers: Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VIM0423 to determine if it can improve symptoms for people with dystonia, a condition causing involuntary muscle contractions. Researchers aim to assess whether this treatment aids daily activities and if it is safe and well-tolerated. Participants are divided into groups, with some receiving VIM0423 and others a placebo (a non-active treatment), to compare results. Individuals with dystonia affecting at least two body parts for over a year might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are being treated with BoNT (a type of injection for muscle conditions), you must meet certain criteria to participate.

Is there any evidence suggesting that VIM0423 is likely to be safe for humans?

Research shows that VIM0423 is being tested for its safety and effectiveness in treating isolated dystonia. 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 people. Unwanted effects were usually mild, such as headaches or mild stomach upset, which are common with many medications.

Since VIM0423 is now in an advanced stage of testing, earlier trials did not find any serious safety issues. This is a positive sign for those considering joining the trial. However, as with any study, new information could emerge, so staying informed and discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dystonia?

Most treatments for dystonia, like botulinum toxin injections or oral medications, work by temporarily relaxing overactive muscles or altering neurotransmitter levels. But VIM0423 is unique because it targets the underlying neural pathways differently, potentially providing a more precise and lasting relief. Unlike those standard treatments, VIM0423 may offer benefits with fewer side effects and less frequent dosing. Researchers are excited about its potential to improve the quality of life for patients with both segmental/multifocal and generalized forms of dystonia, particularly because of its novel approach and promising preliminary results.

What evidence suggests that VIM0423 might be an effective treatment for dystonia?

Research has shown that VIM0423 might alleviate symptoms of dystonia, a movement disorder causing involuntary muscle contractions. In earlier studies, participants taking VIM0423 experienced better outcomes than those not taking the drug. This trial will divide participants into different arms, with some receiving VIM0423 and others a placebo. Although still under investigation, VIM0423 is intended as a new oral medication for dystonia, potentially offering a more effective and safer way to manage symptoms. Ongoing studies aim to confirm these early positive findings. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with isolated dystonia, a movement disorder affecting at least two body regions for over a year. Candidates can be untreated or meet specific criteria if treated with BoNT (a toxin used in dystonia). Pregnant women and those not meeting baseline symptom scores are excluded.

Inclusion Criteria

I am a man or a nonpregnant woman aged 18 to 65.

I have been diagnosed with dystonia in two or more body regions for over a year.

My baseline scores on BFM and CGI-S meet the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 14 weeks

2 visits (in-person)

Treatment

Participants receive either VIM0423 or placebo with dose titration, maintenance, and tapering

16 weeks

3 visits (in-person)

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VIM0423

Trial Overview

The Stride Dystonia study tests VIM0423's effectiveness and safety against a placebo in improving symptoms, tolerability, daily function, and life quality in individuals with isolated dystonia. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo.

How Is the Trial Designed?

Group I: Segmental/multifocal Active Active Control 1 Intervention

Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected receiving active n\~40

Group II: Generalized Active Active Control 1 Intervention

Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving active n\~10

Group III: Segmental/multifocal Placebo Placebo Group 1 Intervention

Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected) receiving placebo n\~40

Group IV: Generalized Placebo Placebo Group 1 Intervention

Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving placebo n\~10

Who Is Running the Clinical Trial?

Vima Therapeutics

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07304089

A Study to Evaluate the Efficacy, Safety, and Tolerability of ...

The main objectives of this clinical trial are to determine the following: Does VIM0423 therapy improve dystonia symptoms compared to placebo?

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07111663

An Observational Study of Individuals With Isolated Dystonia

This is an observational study in individuals with isolated (or primary) dystonia that involves more than one body region. The purpose of the study is to ...

3.

withpower.com

withpower.com/trial/phase-2-dystonia-2026-4850b

VIM0423 for Dystonia · Info for Participants

The Stride Dystonia study tests VIM0423's effectiveness and safety against a placebo in improving symptoms, tolerability, daily function, and ...

4.

synapse.patsnap.com

synapse.patsnap.com/article/vima-secures-60m-for-mid-stage-oral-dystonia-trials

Vima secures $60M for mid-stage oral dystonia trials

Vima Therapeutics hopes that their novel approach with VIM0423 will offer a more effective and safer treatment for dystonia, thus addressing a ...

5.

natlawreview.com

natlawreview.com/press-releases/vima-therapeutics-launches-advance-first-oral-therapy-people-dystonia-and

Vima Therapeutics Launches to Advance the First Oral ...

- VIM0423, a potential first-in-class oral medicine for isolated dystonia, is currently being studied in a Phase 1 clinical trial; Phase 2 ...

6.

synapse.patsnap.com

synapse.patsnap.com/article/vima-therapeutics-debuts-oral-therapy-for-dystonia-and-movement-disorders

Vima Therapeutics Debuts Oral Therapy for Dystonia and ...

VIM0423 aims to overcome these limitations with enhanced pharmacology, efficacy, and safety. David Grayzel, MD, co-founder and chair of ...