Recruiting

Phase 2

VIM0423A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia

Sponsor:

Vima Therapeutics

Code:

NCT07304089

Conditions

Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

VIM0423

VIM0423 Placebo

Study Details

Brief 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?

Conditions

Dystonia

Study ID

NCT07304089

Start date

Feb 5, 2026

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Segmental/multifocal Active

Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected receiving active n\~40

placebo comparator: Segmental/multifocal Placebo

Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected) receiving placebo n\~40

active comparator: Generalized Active

Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving active n\~10

placebo comparator: Generalized Placebo

Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving placebo n\~10

Interventions

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

Primary outcome measure

Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale [ Time Frame: From baseline to Week 14 ]

Central Contacts and Locations

Central contacts

Study Director

617-430-7027 Clinicaltrials@vimatx.com

Locations

Vima Site #033

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #039

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #004

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #028

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #042

Recruiting

Irvine, California, United States, 92614

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #019

Recruiting

Denver, Colorado, United States, 80113

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #009

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #008

Recruiting

Miami, Florida, United States, 33176

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #031

Recruiting

Orlando, Florida, United States, 32825

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #005

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #027

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #041

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #043

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #007

Recruiting

Olney, Maryland, United States, 20832

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #032

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #037

Recruiting

East Lansing, Michigan, United States, 48824

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #002

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #038

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #014

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #018

Recruiting

New York, New York, United States, 10019

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #024

Recruiting

New York, New York, United States, 10021

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #036

Recruiting

Rochester, New York, United States, 14618

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #040

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #035

Recruiting

Cincinnati, Ohio, United States, 45212

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #020

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #021

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #016

Recruiting

Memphis, Tennessee, United States, 38157

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #006

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #026

Recruiting

Georgetown, Texas, United States, 78628

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #012

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #011

Recruiting

Richmond, Virginia, United States, 23233

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #023

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

Vima Site #015

Recruiting

Spokane, Washington, United States, 99202

Contacts

Study Director

617-430-7027 clinicaltrials@vimatx.com

More Information

Sponsor

Vima Therapeutics

Last update posted

Aug 4, 2026

Last verified

Apr, 2026

Keywords

Dystonia
Isolated Dystonia
Primary Dystonia
Cervical Dystonia
Segmental Dystonia
Multi-focal Dystonia
Generalized Dystonia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vima Therapeutics on 2026-08-04.