← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07304089). StuddyBuddy aggregates publicly available trial information.