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RECRUITING Phase 2 ClinicalTrials.gov

A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia

Sponsor: Vima Therapeutics • ClinicalTrials.gov ID: NCT07304089

Registry updated: 2026-09-15
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Description

Stride Dystonia is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of VIM0423 in individuals with isolated dystonia. The main objectives of this clinical trial are to determine the following: * Does VIM0423 therapy improve dystonia symptoms compared to placebo? * Is VIM0423 well tolerated in individuals with isolated dystonia? and * Do the therapeutic effects of VIM0423 confer improvements on daily function and quality of life?

Interventions

  • VIM0423 (Drug)
    VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
  • VIM0423 Placebo (Drug)
    Matching VIM0423 placebo product containing no active ingredient

Eligibility criteria

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.

Conditions

Dystonia

Locations

  • Vima Site #033 — Birmingham, Alabama, United States
  • Vima Site #039 — Scottsdale, Arizona, United States
  • Vima Site #004 — Scottsdale, Arizona, United States
  • Vima Site #028 — Sun City, Arizona, United States
  • Vima Site #042 — Irvine, California, United States
  • Vima Site #030 — Los Angeles, California, United States
  • Vima Site #019 — Denver, Colorado, United States
  • Vima Site #009 — Gainesville, Florida, United States
  • Vima Site #008 — Miami, Florida, United States
  • Vima Site #031 — Orlando, Florida, United States
  • Vima Site #005 — Atlanta, Georgia, United States
  • Vima Site #027 — Chicago, Illinois, United States
  • Vima Site #041 — Overland Park, Kansas, United States
  • Vima Site #043 — Baltimore, Maryland, United States
  • Vima Site #007 — Olney, Maryland, United States
  • Vima Site #032 — Boston, Massachusetts, United States
  • Vima Site #037 — East Lansing, Michigan, United States
  • Vima Site #002 — Farmington Hills, Michigan, United States
  • Vima Site #038 — St Louis, Missouri, United States
  • Vima Site #014 — Albuquerque, New Mexico, United States
  • Vima Site #055 — Amherst, New York, United States
  • Vima Site #018 — New York, New York, United States
  • Vima Site #024 — New York, New York, United States
  • Vima Site #036 — Rochester, New York, United States
  • Vima Site #040 — Fayetteville, North Carolina, United States
  • Vima Site #035 — Cincinnati, Ohio, United States
  • Vima Site #029 — Portland, Oregon, United States
  • Vima Site #020 — Philadelphia, Pennsylvania, United States
  • Vima Site #021 — Charleston, South Carolina, United States
  • Vima Site #016 — Memphis, Tennessee, United States
  • Vima Site #006 — Nashville, Tennessee, United States
  • Vima Site #025 — Dallas, Texas, United States
  • Vima Site #026 — Georgetown, Texas, United States
  • Vima Site #012 — Houston, Texas, United States
  • Vima Site #013 — Houston, Texas, United States
  • Vima Site #011 — Richmond, Virginia, United States
  • Vima Site #023 — Kirkland, Washington, United States
  • Vima Site #015 — Spokane, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record