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Recruiting NCT07304089

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

Conditions: Dystonia

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: Vima Therapeutics

Location: Vima Site #033 Birmingham Alabama

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?

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07304089). StuddyBuddy aggregates publicly available trial information.