RecruitingPhase 2

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

United States100 participantsStarted 2026-02-05

Plain-language summary

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?

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale

Timeframe: From baseline to Week 14

Trial details

NCT IDNCT07304089

SponsorVima Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Study Director

617-430-7027 Clinicaltrials@vimatx.com

View on ClinicalTrials.gov More Dystonia trials