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

NCT07304089 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VIM0423-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 37

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale

  0-150, higher score worse

  From baseline to Week 14

Secondary Outcomes (4)

• Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician

  From baseline to Week 14

• Change from baseline in the Toronto Western Spasmodic Torticollis Rating Scale including head tremor (TWSTRS; as applicable)

  From baseline to Week 14

• Clinical Global Impression of Change (CGI-C)

  From baseline to Week 14

• Patient Global Impression of Change (PGI-C)

  From baseline to Week 14

Other Outcomes (1)

• Incidence and severity of treatment emergent adverse events (TEAEs)

  From baseline to Week 14

Study Arms (4)

Segmental/multifocal Active

ACTIVE COMPARATOR

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

Drug: VIM0423

Segmental/multifocal Placebo

PLACEBO COMPARATOR

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

Drug: VIM0423 Placebo

Generalized Active

ACTIVE COMPARATOR

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

Drug: VIM0423

Generalized Placebo

PLACEBO COMPARATOR

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

Drug: VIM0423 Placebo

Interventions

VIM0423 DRUG

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

Generalized Active; Segmental/multifocal Active

VIM0423 Placebo DRUG

Matching VIM0423 placebo product containing no active ingredient

Generalized Placebo; Segmental/multifocal Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Vima Therapeutics: lead

Study Sites (37)

Vima Site #033

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Vima Site #039

Scottsdale, Arizona, 85251, United States

NOT YET RECRUITING

Vima Site #004

Scottsdale, Arizona, 85258, United States

RECRUITING

Vima Site #028

Sun City, Arizona, 85351, United States

NOT YET RECRUITING

Vima Site #042

Irvine, California, 92614, United States

NOT YET RECRUITING

Vima Site #030

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Vima Site #019

Denver, Colorado, 80113, United States

RECRUITING

Vima Site #009

Gainesville, Florida, 32608, United States

NOT YET RECRUITING

Vima Site #008

Miami, Florida, 33176, United States

NOT YET RECRUITING

Vima Site #031

Orlando, Florida, 32825, United States

RECRUITING

Vima Site #005

Atlanta, Georgia, 30329, United States

NOT YET RECRUITING

Vima Site #027

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Vima Site #041

Overland Park, Kansas, 66211, United States

NOT YET RECRUITING

Vima Site #043

Baltimore, Maryland, 21237, United States

NOT YET RECRUITING

Vima Site #007

Olney, Maryland, 20832, United States

RECRUITING

Vima Site #032

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Vima Site #037

East Lansing, Michigan, 48824, United States

NOT YET RECRUITING

Vima Site #002

Farmington Hills, Michigan, 48334, United States

RECRUITING

Vima Site #038

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

Vima Site #014

Albuquerque, New Mexico, 87106, United States

RECRUITING

Vima Site #024

New York, New York, 10019, United States

NOT YET RECRUITING

Vima Site #024

New York, New York, 10021, United States

RECRUITING

Vima Site #036

Rochester, New York, 14618, United States

NOT YET RECRUITING

Vima Site #040

Fayetteville, North Carolina, 28304, United States

RECRUITING

Vima Site #035

Cincinnati, Ohio, 45212, United States

NOT YET RECRUITING

Vima Site #029

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Vima Site #020

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Vima Site #021

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

Vima Site #016

Memphis, Tennessee, 38157, United States

RECRUITING

Vima Site #006

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Vima Site #025

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Vima Site #026

Georgetown, Texas, 78628, United States

RECRUITING

Vima Site #012

Houston, Texas, 77030, United States

RECRUITING

Vima Site #013

Houston, Texas, 77030, United States

NOT YET RECRUITING

Vima Site #011

Richmond, Virginia, 23233, United States

RECRUITING

Vima Site #023

Kirkland, Washington, 98034, United States

RECRUITING

Vima Site #015

Spokane, Washington, 99202, United States

RECRUITING

Related Links

• https://www.stridedystonia.com/

MeSH Terms

Conditions

Dystonia; Dystonic Disorders; Torticollis

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Central Study Contacts

Study Director

CONTACT

617-430-7027; Clinicaltrials@vimatx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study sponsor, participants, the CRO, Investigator, and all site personnel (except pharmacists and pharmacy staff) will be blinded to treatment assignments until the database has been locked and restricted from further edits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel cohorts of participants receiving active or placebo drug products

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 26, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)