Isolated/Primary Dystonia That Affects More Than One Region of the BodyNCT07111663
An Observational Study of Individuals With Isolated Dystonia
An observational study of Isolated/Primary Dystonia That Affects More Than One Region of the Body, run by Vima Therapeutics at 29 sites in United States.
Trial summary
This is an observational study in individuals with isolated (or primary) dystonia that involves more than one body region. The purpose of the study is to collect detailed information to help your physician and other researchers understand how dystonia impacts your and other patients' lives and how the disease changes… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Isolated/Primary Dystonia That Affects More Than One Region of the Body
- How many people
- 200 participants
- Where
- 29 sitesUnited States
- Study dates
- 17 Jun 2025to Oct 2026
- Phase
- Observational
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Isolated (Primary) Dystonia
Inclusion Criteria: Each participant must meet the following criteria at Visit 1 to be eligible to continue in the study:
- The participant is willing to sign an informed consent form indicating that he/she understands the purpose of the study; understands and can perform, complete, and comply with all the assessments that are required during the study; and is willing to participate in the study.
- The participant is a male or female between 12 and 65 years of age (inclusive).
- The participant has a clinical diagnosis of isolated (or primary) dystonia for at least one year prior to Visit 1 and meets the study definition of segmental/multifocal or generalized dystonia at Visit 1.
Exclusion Criteria: Any participant who meets any of the following criteria at Visit 1 will be excluded from this study:
- The participant has a diagnosis of focal dystonia at Visit 1.
- The participant has a diagnosis of dopa-responsive dystonia, secondary dystonia, or psychogenic/functional dystonia.
- The participant has any significant ongoing disease, disorder, laboratory abnormalities, alcohol or illicit drug abuse or dependence, environmental factor, or any ongoing or history of any medical or surgical condition that in the judgment of the investigator, in consultation with the medical monitor and/or sponsor's designee, might jeopardize the participant's safety, impact the scientific objectives of the clinical study, or interfere with participation in the clinical study.
- The participant has a history of any psychiatric or cognitive impairment disorder that, in the opinion of the investigator, may interfere with study conduct.
- The participant has had myotomy or denervation surgery in any affected muscles (e.g., peripheral denervation and/or spinal cord stimulation).
- The participant has marked limitation on passive range of motion that suggests contractures or other structural abnormality (e.g., cervical contractures or cervical spine syndrome).
- The participant has undergone deep brain stimulation (DBS) surgery (even if implant deactivated).
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Vima Site #014
Albuquerque, New Mexico, 87106
Vima Site #010
Aliso Viejo, California, 92656
Vima Site #005
Atlanta, Georgia, 30322
Vima Site #003
Boca Raton, Florida, 33486
Vima Site #021
Charleston, South Carolina, 29407
Vima Site #027
Chicago, Illinois, 60611
Vima Site #017
Commack, New York, 11725
Vima Site #025
Dallas, Texas, 75390
Vima Site #019
Englewood, Colorado, 80113
Vima Site #002
Farmington Hills, Michigan, 48334
Vima Site #009
Gainesville, Florida, 32611
Vima Site #026
Georgetown, Texas, 78628
Vima Site #012
Houston, Texas, 77030
Vima Site #023
Kirkland, Washington, 98034
Vima Site #030
Los Angeles, California, 97239
Vima Site #016
Memphis, Tennessee, 38157
Vima Site #008
Miami, Florida, 33176
Vima Site #006
Nashville, Tennessee, 37232
Vima Site #018
New York, New York, 10029
Vima Site #024
New York, New York, 10065
Vima Site #007
Olney, Maryland, 20832
Vima Site #031
Orlando, Florida, 32825
Vima Site #022
Palo Alto, California, 94301
Vima Site #020
Philadelphia, Pennsylvania, 19107
Vima Site #029
Portland, Oregon, 97239
Vima Site #011
Richmond, Virginia, 23298
Vima Site #004
Scottsdale, Arizona, 85258
Vima Site #015
Spokane, Washington, 99202
Vima Site #028
Sun City, Arizona, 85351
About this study
This is an observational study in individuals with isolated (or primary) dystonia that involves more than one body region. The purpose of the study is to collect detailed information to help your physician and other researchers understand how dystonia impacts your and other patients' lives and how the disease changes over time. The study may also help researchers better understand the clinical scales that are commonly used to evaluate dystonia symptoms and how they affect various areas of life such as well-being, pain, relationships and social interactions, and progress over time. Because this is an observational study, you will not receive any interventional treatment in the study.
Read the detailed description
The primary goal of this observational study is to further characterize and quantify disease severity and impact (including change over time) in individuals with either segmental, multifocal, or generalized dystonia in a structured manner, utilizing and comparing various well-known scales. In addition, medication history and any intercurrent events related to the participant's health (such as, but not limited to, hospitalizations, new diagnoses, etc.) will be captured. This study will provide standardized data to support planned future interventional clinical studies in this patient population and will provide a greater understanding of the population under study and the performance of clinical ratings scales.
- Keywords
- Dystonia, Isolated Dystonia, Primary Dystonia, Cervical 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.
| Study group | Role | What they receive |
|---|---|---|
| Isolated (or Primary) Dystonia Cohort | This is a single-arm noninterventional, prospective observational study enrolling up to 200 male and female participants (ages 12 - 65 years, inclusive) that have been diagnosed with isolated dystonia for at least one year prior to the first study visit. Candidates with focal dystonia (i.e., only one body part affected) are not eligible for participation. However, the Investigator may query such patients to determine if symptoms have spread to other regions, which may allow them to be eligible for study entry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
The BFM was developed to quantitatively assess primary dystonias (Burke 1985). It is composed of 2 subscales: a movement subscale, based on the clinician's evaluation of the patient in nine body areas, and a disability subscale, based on the participant's report of disability in activities of daily living.
Measured: From start of treatment through 4 months
Secondary outcomes (2)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-2)
The TWSTRS-2 scale is used to assess cervical dystonia. It includes 3 subscales that evaluate symptom severity, disability, and pain. The severity scale is clinician-rated and the disability scale is patient-rated based on 6 items related to work, activities of daily living, driving, reading, watching TV, and outside activities.
Measured: From start of treatment through 4 months
Clinical Global Impression of Severity (CGI-S)
The CGI-S score is used by the Investigator to determine, in a global sense, how severe the patients' blepharospasm is in the context of other blepharospasm patients. Increased scores indicate more severe symptoms.
Measured: From start of treatment through 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start17 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated/Primary Dystonia That Affects More Than One Region of the BodyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT07111663
- Sponsor's protocol ID
- VIM0423-401
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Individuals With Isolated Dystonia
- ClinicalTrials.gov ID
- NCT07111663
- Acronym / sponsor ID
- VIM0423-401
- Keywords
- Dystonia, Isolated Dystonia, Primary Dystonia, Cervical Dystonia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vima TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Aug 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.
This is an observational study in individuals with isolated (or primary) dystonia that involves more than one body region. The purpose of the study is to collect detailed information to help your physician and other researchers understand how dystonia impacts your and other patients' lives and how the disease changes over time. The study may also help researchers better understand the clinical scales that are commonly used to evaluate dystonia symptoms and how they affect various areas of life such as well-being, pain, relationships and social interactions, and progress over time. Because this is an observational study, you will not receive any interventional treatment in the study.
Detailed description
The primary goal of this observational study is to further characterize and quantify disease severity and impact (including change over time) in individuals with either segmental, multifocal, or generalized dystonia in a structured manner, utilizing and comparing various well-known scales. In addition, medication history and any intercurrent events related to the participant's health (such as, but not limited to, hospitalizations, new diagnoses, etc.) will be captured. This study will provide standardized data to support planned future interventional clinical studies in this patient population and will provide a greater understanding of the population under study and the performance of clinical ratings scales.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolated (or Primary) Dystonia Cohort | – | –This is a single-arm noninterventional, prospective observational study enrolling up to 200 male and female participants (ages 12 - 65 years, inclusive) that have been diagnosed with isolated dystonia for at least one year prior to the first study visit. Candidates with focal dystonia (i.e., only one body part affected) are not eligible for participation. However, the Investigator may query such patients to determine if symptoms have spread to other regions, which may allow them to be eligible for study entry. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Isolated (Primary) Dystonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Burke-Fahn-Marsden (BFM) Dystonia Rating Scale
Time frame: From start of treatment through 4 months
The BFM was developed to quantitatively assess primary dystonias (Burke 1985). It is composed of 2 subscales: a movement subscale, based on the clinician's evaluation of the patient in nine body areas, and a disability subscale, based on the participant's report of disability in activities of daily living.
2 secondary outcomes
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-2)
Time frame: From start of treatment through 4 months
Clinical Global Impression of Severity (CGI-S)
Time frame: From start of treatment through 4 months
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 21 Sep 2026.
- https://www.stridedystonia.com/Link provided by the sponsor.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolated/Primary Dystonia That Affects More Than One Region of the Body, run by Vima Therapeutics at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burke-Fahn-Marsden (BFM) Dystonia Rating Scale (time frame: From start of treatment through 4 months). 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 21 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.