A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
ConditionDystonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVima Therapeutics
About this trial
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
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- VIM0423
- VIM0423 Placebo
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov