A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Recruiting
Phase 2Interventional Study
Dystonia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Vima Therapeutics · Industry
Who this trial is looking for
This trial is looking for adults with isolated dystonia to help test a new treatment called VIM0423. Participants will receive either VIM0423 or a placebo to see how well it works and if it is safe.
Are You a Good Fit for This Trial?
You may be able to join if
I am a man or a nonpregnant woman aged 18 to 65 years old.
I have been diagnosed with isolated dystonia for at least one year.
I have two or more body regions affected by dystonia.
I meet the specific scoring requirements for my condition.
You may not be able to join if
I am pregnant.
I have not been diagnosed with isolated dystonia.
I have had certain treatments that do not meet trial criteria.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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?
Trial Locations
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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 …
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.
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