A Phase 2 interventional study of VIM0423 and VIM0423 Placebo in Dystonia, sponsored by Vima Therapeutics. Recruiting at 45 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Vima Therapeutics · Phase 2, Interventional, and Treatment
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:
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 24 weeks and requires 6 in person visits. The study schedule includes Screening and Baseline (up to 6 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.
213 studies on the registry are indexed under Dystonia; 54 are open to participants now.
This study's planned enrollment of 100 is above the median of 28 across 114 interventional studies indexed under Dystonia.
Browse Dystonia studies →Vima Therapeutics is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected receiving active n\~40
Drug: VIM0423
Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected) receiving placebo n\~40
Drug: VIM0423 Placebo
Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving active n\~10
Drug: VIM0423
Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving placebo n\~10
Drug: VIM0423 Placebo
VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
Matching VIM0423 placebo product containing no active ingredient
Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
0-150, higher score worse
Time frame: From baseline to Week 14
Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician
1-7, higher score worse
Time frame: From baseline to Week 14
Change from baseline in the Toronto Western Spasmodic Torticollis Rating Scale including head tremor (TWSTRS; as applicable)
0-85, higher score worse
Time frame: From baseline to Week 14
Clinical Global Impression of Change (CGI-C)
1-7, higher score worse
Time frame: From baseline to Week 14
Patient Global Impression of Change (PGI-C)
1-7, higher score worse
Time frame: From baseline to Week 14
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: From baseline to Week 14
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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