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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-05-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Dystonia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel cohorts of participants receiving active or placebo drug products

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

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VIM0423

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

Intervention Type DRUG

VIM0423 Placebo

Matching VIM0423 placebo product containing no active ingredient

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Segmental/multifocal Active

VIM0423

Segmental/multifocal Placebo

VIM0423 Placebo

Generalized Active

VIM0423

Generalized Placebo

VIM0423 Placebo

Interventions

VIM0423

VIM0423 Placebo

Eligibility Criteria

Inclusion Criteria

Sponsors

Vima Therapeutics

Responsible Party

Locations

Vima Site #004

Vima Site #019

Vima Site #031

Vima Site #007

Vima Site #035

Vima Site #002

Vima Site #020

Vima Site #025

Vima Site #015

Countries

Central Contacts

Study Director

Facility Contacts

Study Director

Study Director

Study Director

Study Director

Study Director

Study Director

Study Director

Study Director

Study Director

Other Identifiers

VIM0423-201