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Observing people with isolated (primary) dystonia affecting multiple body regions

An Observational Study of Individuals With Isolated Dystonia

Observational Vima Therapeutics · NCT07111663

This project will see how isolated (primary) dystonia that affects more than one body region changes over time and how commonly used clinical rating scales relate to symptoms and daily life in people aged 12–65.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages12 Years to 65 Years
SexAll
SponsorVima Therapeutics Industry-sponsored
Locations29 sites (Scottsdale, Arizona and 28 other locations)
Trial IDNCT07111663 on ClinicalTrials.gov

What this trial studies

This observational project enrolls people aged 12–65 with segmental, multifocal, or generalized isolated (primary) dystonia and follows them over time without offering any experimental treatments. At scheduled visits researchers collect standardized clinical rating scales, medication histories, and any intercurrent health events, and compare the performance of different scales for severity and impact. The study also captures patient-reported outcomes such as pain, well-being, relationships, and social function to understand real-world effects. Data will be used to standardize measurements and support future interventional clinical trials in this population.

Who should consider this trial

Good fit: Ideal candidates are people aged 12–65 with a clinical diagnosis of isolated (primary) dystonia affecting more than one body region (segmental, multifocal, or generalized) for at least one year who can consent and complete study assessments.

Not a fit: People with focal dystonia, dopa-responsive dystonia, secondary dystonia, or psychogenic/functional dystonia, and those seeking interventional therapy, are unlikely to receive direct clinical benefit from this observational protocol.

Why it matters

Potential benefit: If successful, the study could help doctors and researchers measure dystonia more accurately and guide future treatment trials that may improve patient care.

How similar studies have performed: Prior observational and natural-history studies and scale-validation work in dystonia have provided useful insights for clinical trials, but comprehensive data focused on multi-region isolated dystonia are still limited.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Scottsdale, Arizona and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Isolated/Primary Dystonia That Affects More Than One Region of the BodyDystonia, Isolated Dystonia, Primary Dystonia, Cervical Dystonia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.