An Observational Study of Individuals With Isolated Dystonia
NCT ID: NCT07111663
Last Updated: 2025-11-03
Study Results
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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RECRUITING
200 participants
OBSERVATIONAL
2025-06-17
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
12 Years
65 Years
ALL
No
Sponsors
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Vima Therapeutics
INDUSTRY
Responsible Party
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Locations
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Vima Site #004
Scottsdale, Arizona, United States
Vima Site #028
Sun City, Arizona, United States
Vima Site #010
Aliso Viejo, California, United States
Vima Site #030
Los Angeles, California, United States
Vima Site #022
Palo Alto, California, United States
Vima Site #019
Englewood, Colorado, United States
Vima Site #003
Boca Raton, Florida, United States
Vima Site #009
Gainesville, Florida, United States
Vima Site #008
Miami, Florida, United States
Vima Site #031
Orlando, Florida, United States
Vima Site #005
Atlanta, Georgia, United States
Vima Site #027
Chicago, Illinois, United States
Vima Site #007
Olney, Maryland, United States
Vima Site #002
Farmington Hills, Michigan, United States
Vima Site #014
Albuquerque, New Mexico, United States
Vima Site #017
Commack, New York, United States
Vima Site #018
New York, New York, United States
Vima Site #024
New York, New York, United States
Vima Site #029
Portland, Oregon, United States
Vima Site #020
Philadelphia, Pennsylvania, United States
Vima Site #021
Charleston, South Carolina, United States
Vima Site #016
Memphis, Tennessee, United States
Vima Site #006
Nashville, Tennessee, United States
Vima Site #025
Dallas, Texas, United States
Vima Site #026
Georgetown, Texas, United States
Vima Site #012
Houston, Texas, United States
Vima Site #011
Richmond, Virginia, United States
Vima Site #023
Kirkland, Washington, United States
Vima Site #015
Spokane, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VIM0423-401
Identifier Type: -
Identifier Source: org_study_id
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