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

Condition(s) studied

Investigational drug(s) / intervention(s)

VIM0423: VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)

VIM0423 Placebo: Matching VIM0423 placebo product containing no active ingredient

Study 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

Primary outcome measure(s)

• Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale — From baseline to Week 14
  0-150, higher score worse

Trial sites (38)