VIM0423 for adults with isolated dystonia affecting multiple body regions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Stride Dystonia (VIM0423-201) is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial testing once-daily oral VIM0423 in adults with isolated dystonia affecting two or more body regions. VIM0423 is intended to correct a chemical imbalance in brain regions thought to cause dystonia. About 120 participants will be randomized to VIM0423 or placebo and followed for measures of symptom severity, daily function, and quality of life while safety and tolerability are monitored. Key outcome measures include dystonia rating scales (e.g., BFM), clinician global impression, patient-reported function, and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant must be male or nonpregnant female between 18 and 70 years of age (inclusive) at Visit 1 (Screening).
* The participant has a clinical diagnosis of isolated dystonia with symptoms consistent with dystonia for at least one year prior to Visit 1 (Screening); has two or more body regions affected by dystonia at Visit 1 (Screening); and has been confirmed by Investigator and Enrollment Authorization Committee.
* The participant may be untreated with BoNT; OR if the participant is being treated with BoNT as part of their standard of care for dystonia, they must meet protocol-specified criteria.
* The participants must meet protocol-specified requirements for baseline scores on the BFM and CGI-S.

Where it's running

• Vima Site #033
  Birmingham, Alabama, United States Recruiting
• Vima Site #039
  Scottsdale, Arizona, United States Recruiting
• Vima Site #004
  Scottsdale, Arizona, United States Recruiting
• Vima Site #028
  Sun City, Arizona, United States Recruiting
• Vima Site #042
  Irvine, California, United States Recruiting
• Vima Site #030
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: Clinicaltrials@vimatx.com
• Phone: 617-430-7027

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Measuring brain network activity to predict and improve outcomes in children with dystonia

  This project will test whether noninvasive brain and muscle recordings, and comparing DBS on versus off, can predict and help improve motor outcomes for children with dystonia.

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• Wearable sensors to predict DBS results for people with dystonia

  This study will test whether wearable sensors that record walking patterns before surgery can predict how well deep brain stimulation will work for people with dystonia.

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• Using GPi brain signals to guide DBS programming for primary dystonia

  This study will test whether recording local field potentials from the globus pallidus interna with the Medtronic Percept device can help guide DBS programming and improve symptoms in adults with primary dystonia.

  Recruiting Newcastle-upon-Tyne Hospitals NHS Trust · Newcastle upon Tyne, Tyne & Wear · NCT07309133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.