NCT07111663 An Observational Study of Individuals With Isolated Dystonia
| NCT ID | NCT07111663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vima Therapeutics |
| Condition | Isolated/Primary Dystonia That Affects More Than One Region of the Body |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-06-17 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07111663 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Isolated/Primary Dystonia That Affects More Than One Region of the Body. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111663 currently recruiting?
Yes, NCT07111663 is actively recruiting participants. Contact the research team at clinicaltrials@vimatx.com for enrollment information.
Where is the NCT07111663 trial being conducted?
This trial is being conducted at Scottsdale, United States, Sun City, United States, Aliso Viejo, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT07111663 clinical trial?
NCT07111663 is sponsored by Vima Therapeutics. The trial plans to enroll 200 participants.