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VIM0423 for adults with isolated dystonia affecting multiple body regions

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia (Stride Dystonia)

Phase 2 Interventional Vima Therapeutics · NCT07304089

This trial will test a once-daily oral medicine called VIM0423 to see if it reduces dystonia symptoms and improves daily function in adults with isolated dystonia that affects two or more body regions.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorVima Therapeutics Industry-sponsored
Locations37 sites (Birmingham, Alabama and 36 other locations)
Trial IDNCT07304089 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–65 with a clinical diagnosis of isolated dystonia for at least one year and two or more affected body regions who meet baseline rating-scale criteria (and stable or no botulinum toxin treatment per protocol) are ideal candidates.

Not a fit: People whose dystonia affects only a single region, those outside the 18–65 age range, pregnant individuals, or those with secondary dystonia are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If effective, VIM0423 could provide the first oral therapy that reduces dystonia symptoms across multiple body regions and improves daily function and quality of life.

How similar studies have performed: Approved botulinum toxin injections work for some focal dystonias, and prior oral medications have given limited or inconsistent benefit, so an oral drug that treats multiple regions would be a relatively novel but plausible advance.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant must be male or nonpregnant female between 18 and 65 years of age (inclusive) at Visit 1 (Screening).
* The participant has a clinical diagnosis of isolated 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 this trial is running

Birmingham, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DystoniaIsolated DystoniaPrimary DystoniaCervical DystoniaSegmental DystoniaMulti-focal DystoniaGeneralized Dystonia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.