An Observational Study of Individuals With Isolated Dystonia

NCT07111663 | Recruiting

• 1 other identifier: VIM0423-401
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 29

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.

Conditions

Isolated/Primary Dystonia That Affects More Than One Region of the Body

Keywords

Dystonia, Isolated Dystonia, Primary Dystonia, Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of treatment through 4 months

Secondary Outcomes (2)

• Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-2)

  From start of treatment through 4 months

• Clinical Global Impression of Severity (CGI-S)

  From start of treatment through 4 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Isolated (Primary) Dystonia

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vima Therapeutics: lead

Study Sites (29)

Vima Site #004

Scottsdale, Arizona, 85258, United States

RECRUITING

Vima Site #028

Sun City, Arizona, 85351, United States

RECRUITING

Vima Site #010

Aliso Viejo, California, 92656, United States

RECRUITING

Vima Site #030

Los Angeles, California, 97239, United States

RECRUITING

Vima Site #022

Palo Alto, California, 94301, United States

RECRUITING

Vima Site #019

Englewood, Colorado, 80113, United States

RECRUITING

Vima Site #003

Boca Raton, Florida, 33486, United States

RECRUITING

Vima Site #009

Gainesville, Florida, 32611, United States

RECRUITING

Vima Site #008

Miami, Florida, 33176, United States

RECRUITING

Vima Site #031

Orlando, Florida, 32825, United States

RECRUITING

Vima Site #005

Atlanta, Georgia, 30322, United States

RECRUITING

Vima Site #027

Chicago, Illinois, 60611, United States

RECRUITING

Vima Site #007

Olney, Maryland, 20832, United States

RECRUITING

Vima Site #002

Farmington Hills, Michigan, 48334, United States

RECRUITING

Vima Site #014

Albuquerque, New Mexico, 87106, United States

RECRUITING

Vima Site #017

Commack, New York, 11725, United States

RECRUITING

Vima Site #018

New York, New York, 10029, United States

RECRUITING

Vima Site #024

New York, New York, 10065, United States

RECRUITING

Vima Site #029

Portland, Oregon, 97239, United States

RECRUITING

Vima Site #020

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Vima Site #021

Charleston, South Carolina, 29407, United States

RECRUITING

Vima Site #016

Memphis, Tennessee, 38157, United States

RECRUITING

Vima Site #006

Nashville, Tennessee, 37232, United States

RECRUITING

Vima Site #025

Dallas, Texas, 75390, United States

RECRUITING

Vima Site #026

Georgetown, Texas, 78628, United States

RECRUITING

Vima Site #012

Houston, Texas, 77030, United States

NOT YET RECRUITING

Vima Site #011

Richmond, Virginia, 23298, United States

RECRUITING

Vima Site #023

Kirkland, Washington, 98034, United States

RECRUITING

Vima Site #015

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Dystonia; Dystonic Disorders; Torticollis

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Central Study Contacts

Study Director

CONTACT

617-430-7027; clinicaltrials@vimatx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)