DystoniaPhase 2NCT07304089
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
A Phase 2 study testing VIM0423 in people with Dystonia, run by Vima Therapeutics at 45 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dystonia
- What is being tested?
- VIM0423
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 45 sitesin 2 countries
- Study dates
- 5 Feb 2026to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be male or nonpregnant female between 18 and 70 years of age (inclusive) at Visit 1 (Screening).
- The participant has a clinical diagnosis of isolated dystonia with symptoms consistent with 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.
Who cannot join
None listed.
Trial locations and contacts
45 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 2 countries
United States41 sites, 41 recruiting
- Recruiting
Vima Site #014
Albuquerque, New Mexico, 87106
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Not yet recruiting
Vima Site #055
Amherst, New York, 14226
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #005
Atlanta, Georgia, 30329
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Not yet recruiting
Vima Site #056
Aurora, Colorado, 80045
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #043
Baltimore, Maryland, 21237
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #033
Birmingham, Alabama, 35233
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #032
Boston, Massachusetts, 02215
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #021
Charleston, South Carolina, 29425
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #027
Chicago, Illinois, 60611
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #035
Cincinnati, Ohio, 45212
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #025
Dallas, Texas, 75390
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #019
Denver, Colorado, 80113
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #037
East Lansing, Michigan, 48824
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #002
Farmington Hills, Michigan, 48334
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #040
Fayetteville, North Carolina, 28304
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #009
Gainesville, Florida, 32608
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #026
Georgetown, Texas, 78628
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #012
Houston, Texas, 77030
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #013
Houston, Texas, 77030
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #042
Irvine, California, 92614
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #023
Kirkland, Washington, 98034
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #030
Los Angeles, California, 90048
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #016
Memphis, Tennessee, 38157
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #008
Miami, Florida, 33176
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #006
Nashville, Tennessee, 37232
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #018
New York, New York, 10019
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #024
New York, New York, 10021
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #007
Olney, Maryland, 20832
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #031
Orlando, Florida, 32825
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #041
Overland Park, Kansas, 66211
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #020
Philadelphia, Pennsylvania, 19107
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #029
Portland, Oregon, 97239
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #011
Richmond, Virginia, 23233
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #036
Rochester, New York, 14618
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Not yet recruiting
Vima Site #061
Sacramento, California, 95816
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #039
Scottsdale, Arizona, 85251
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #004
Scottsdale, Arizona, 85258
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #015
Spokane, Washington, 99202
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #038
St Louis, Missouri, 63110
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Recruiting
Vima Site #028
Sun City, Arizona, 85351
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Not yet recruiting
Vima Site #069
Vernon, Connecticut, 06066
Study Director, 617-430-7027, clinicaltrials@vimatx.com
Canada4 sites, 4 recruiting
- Not yet recruiting
Vima Site #059
Calgary, Alberta, T2N 2T8
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Not yet recruiting
Vima Site #070
Ottawa, Ontario, K1Y 4E9
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Not yet recruiting
Vima Site #060
Toronto, Ontario, M5G 2C4
Study Director, 617-430-7027, clinicaltrials@vimatx.com
- Not yet recruiting
Vima Site #068
Vancouver, British Columbia, V6T 2B5
Study Director, 617-430-7027, clinicaltrials@vimatx.com
About this study
Official title: 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?
Read the 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 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.
- Conditions
- Dystonia
- Being tested
- VIM0423, VIM0423 Placebo
- Keywords
- Dystonia, Isolated Dystonia, Primary Dystonia, Cervical Dystonia, Segmental Dystonia, Multi-focal Dystonia, Generalized Dystonia
- Medical subject headings
- Dystonia, Dystonic Disorders, Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIM0423Drug
VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002)
VIM0423 PlaceboDrug
Matching VIM0423 placebo product containing no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Segmental/multifocal Active | Active comparator | Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected receiving active n~40 Receives: Drug: VIM0423 |
| Segmental/multifocal Placebo | Placebo comparator | Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected) receiving placebo n~40 Receives: Drug: VIM0423 Placebo |
| Generalized Active | Active comparator | Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving active n~10 Receives: Drug: VIM0423 |
| Generalized Placebo | Placebo comparator | Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving placebo n~10 Receives: Drug: VIM0423 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
0-150, higher score worse
Measured: From baseline to Week 14
Secondary outcomes (4)
Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician
1-7, higher score worse
Measured: 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
Measured: From baseline to Week 14
Clinical Global Impression of Change (CGI-C)
1-7, higher score worse
Measured: From baseline to Week 14
Patient Global Impression of Change (PGI-C)
1-7, higher score worse
Measured: From baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start5 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel cohorts of participants receiving active or placebo drug products
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vima Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304089
- Sponsor's protocol ID
- VIM0423-201
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07304089
- Acronym / sponsor ID
- VIM0423-201
- Conditions
- Dystonia
- Keywords
- Dystonia, Isolated Dystonia, Primary Dystonia, Cervical Dystonia, Segmental Dystonia, Multi-focal Dystonia, Generalized Dystonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vima TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel cohorts of participants receiving active or placebo drug products
| Arm | Type | Receives |
|---|---|---|
| Segmental/multifocal Active | Active comparator | Drug: VIM0423Segmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected receiving active n~40 |
| Segmental/multifocal Placebo | Placebo comparator | Drug: VIM0423 PlaceboSegmental/Multifocal isolated dystonia (enrolling participants with at least two body parts affected) receiving placebo n~40 |
| Generalized Active | Active comparator | Drug: VIM0423Generalized isolated dystonia (enrolling participants with more than two body parts affected) receiving active n~10 |
| Generalized Placebo | Placebo comparator | Drug: VIM0423 PlaceboGeneralized isolated dystonia (enrolling participants with more than two body parts affected) receiving placebo n~10 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be male or nonpregnant female between 18 and 70 years of age (inclusive) at Visit 1 (Screening).
- The participant has a clinical diagnosis of isolated dystonia with symptoms consistent with 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIM0423VIM0423 is a combination drug product containing two active ingredients (VMA-1001 and VMA-1002) | Drug | Generalized Active, Segmental/multifocal Active |
| VIM0423 PlaceboMatching VIM0423 placebo product containing no active ingredient | Drug | Generalized Placebo, Segmental/multifocal Placebo |
Primary outcome
Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
Time frame: From baseline to Week 14
0-150, higher score worse
4 secondary outcomes
Change from baseline in Clinical Global Impression of Severity (CGI-S) as assessed by the clinician
Time frame: 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
Clinical Global Impression of Change (CGI-C)
Time frame: From baseline to Week 14
Patient Global Impression of Change (PGI-C)
Time frame: From baseline to Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- https://www.stridedystonia.com/Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dystonia
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruiting
Accelerated TMS for Focal Hand Dystonia
Isolated Focal Hand Dystonia
Not yet recruiting
VTS Sensorimotor Neuromodulation in WC
Writer's Cramp, Dystonias
Recruiting
Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
Dystonia, Pediatric
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VIM0423 in people with Dystonia, run by Vima Therapeutics at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (617-430-7027, Clinicaltrials@vimatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Burke-Fahn-Marsden (BFM) Dystonia Rating Scale (time frame: From baseline to Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.