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

June 11, 2026 updated by: Vima Therapeutics

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia (Stride Dystonia)

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Isolated dystonia, previously referred to as primary dystonia, is a rare movement disorder subclassified according to parts of the body affected. Approximately 160,000 individuals in the United States are affected. Dystonia is characterized by sustained muscle contractions which cause abnormal movements and/or postures. These can be patterned, twisting, or tremulous.

Botulinum toxins (BoNT) are the only approved drug products in the US for the treatment of dystonia; however, these injections are only approved for individuals with a diagnosis of cervical (neck) dystonia or blepharospasm (eye lid) and act locally to weaken affected muscles. There are no approved treatment options for approximately 50% of individuals with other subtypes of isolated dystonia that affect more than one body part, and there are no approved oral treatments for dystonia.

VIM0423 is being developed as a once-daily oral medication that will address the root cause of dystonia, which is known to be a chemical imbalance in specific brain regions. As such, VIM0423 is intended to treat most people with isolated dystonia, regardless of the number of body parts affected.

Stride Dystonia (Study VIM0423-201) is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of VIM0423 in adults with isolated dystonia that affects two or more body regions. Up to 120 individuals will be enrolled in the trial.

Participants will be randomized (1:1) to receive either VIM0423 or matching placebo (up to 6 pills a day, taken before bed each evening) for 16 weeks. The Investigator and Participant will not know what patients are receiving VIM0423 or placebo, but that information will be available if needed.

The total time of participation in the trial is up to 32 weeks and requires 6 in person visits. The study schedule includes Screening and Baseline (up to 14 weeks, 2 visits), Dose Titration, Dose Maintenance, Dose Taper (16 weeks, 3 Visits), and Safety follow-up (2 weeks, 1 Visit).

Assessments of changes in dystonia including video recordings will be made by study personnel. Clinical labs, EKGs, and Adverse events will be monitored throughout the study. Participants will be asked to perform self-assessments of their dystonia and its impact on their activities of daily living.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Scottsdale, Arizona, United States, 85258
      • Scottsdale, Arizona, United States, 85251
      • Sun City, Arizona, United States, 85351
    • California
      • Irvine, California, United States, 92614
      • Los Angeles, California, United States, 90048
    • Colorado
      • Denver, Colorado, United States, 80113
    • Florida
      • Gainesville, Florida, United States, 32608
      • Miami, Florida, United States, 33176
      • Orlando, Florida, United States, 32825
    • Georgia
      • Atlanta, Georgia, United States, 30329
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Kansas
      • Overland Park, Kansas, United States, 66211
    • Maryland
      • Baltimore, Maryland, United States, 21237
      • Olney, Maryland, United States, 20832
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • East Lansing, Michigan, United States, 48824
      • Farmington Hills, Michigan, United States, 48334
    • Missouri
      • St Louis, Missouri, United States, 63110
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • New York, New York, United States, 10019
      • New York, New York, United States, 10021
      • Rochester, New York, United States, 14618
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
    • Ohio
      • Cincinnati, Ohio, United States, 45212
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Memphis, Tennessee, United States, 38157
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Dallas, Texas, United States, 75390
      • Georgetown, Texas, United States, 78628
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030
    • Virginia
      • Richmond, Virginia, United States, 23233
    • Washington
      • Kirkland, Washington, United States, 98034
      • Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Segmental/multifocal Active
Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected receiving active n~40
Drug: VIM0423
VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
Placebo Comparator: Segmental/multifocal Placebo
Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected) receiving placebo n~40
Drug: VIM0423 Placebo
Matching VIM0423 placebo product containing no active ingredient
Active Comparator: Generalized Active
Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving active n~10
Drug: VIM0423
VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
Placebo Comparator: Generalized Placebo
Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving placebo n~10
Drug: VIM0423 Placebo
Matching VIM0423 placebo product containing no active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
Time Frame: From baseline to Week 14
0-150, higher score worse
From baseline to Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician
Time Frame: From baseline to Week 14
1-7, higher score worse
From baseline to Week 14
Change from baseline in the Toronto Western Spasmodic Torticollis Rating Scale including head tremor (TWSTRS; as applicable)
Time Frame: From baseline to Week 14
0-85, higher score worse
From baseline to Week 14
Clinical Global Impression of Change (CGI-C)
Time Frame: From baseline to Week 14
1-7, higher score worse
From baseline to Week 14
Patient Global Impression of Change (PGI-C)
Time Frame: From baseline to Week 14
1-7, higher score worse
From baseline to Week 14

Other Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment emergent adverse events (TEAEs)
Time Frame: From baseline to Week 14
From baseline to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vima Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIM0423-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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