An observational study in Isolated/Primary Dystonia That Affects More Than One Region of the Body, sponsored by Vima Therapeutics. Active, not recruiting at 29 sites in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Vima Therapeutics · Observational
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.
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.
319 studies on the registry are indexed under Dystonia; 56 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 126 observational studies indexed under Dystonia.
Browse Dystonia studies →Vima Therapeutics is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Isolated (Primary) Dystonia
Inclusion Criteria: Each participant must meet the following criteria at Visit 1 to be eligible to continue in the study:
Exclusion Criteria: Any participant who meets any of the following criteria at Visit 1 will be excluded from this study:
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.
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.
Time frame: From start of treatment through 4 months
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.
Time frame: 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.
Time frame: From start of treatment through 4 months
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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