An Observational Study of Individuals With Isolated Dystonia

NCT ID: NCT07111663

Last Updated: 2025-11-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-17

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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 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

* 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).
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vima Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vima Site #004

Scottsdale, Arizona, United States

Site Status RECRUITING

Vima Site #028

Sun City, Arizona, United States

Site Status NOT_YET_RECRUITING

Vima Site #010

Aliso Viejo, California, United States

Site Status RECRUITING

Vima Site #030

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Vima Site #022

Palo Alto, California, United States

Site Status RECRUITING

Vima Site #019

Englewood, Colorado, United States

Site Status RECRUITING

Vima Site #003

Boca Raton, Florida, United States

Site Status RECRUITING

Vima Site #009

Gainesville, Florida, United States

Site Status RECRUITING

Vima Site #008

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Vima Site #031

Orlando, Florida, United States

Site Status NOT_YET_RECRUITING

Vima Site #005

Atlanta, Georgia, United States

Site Status RECRUITING

Vima Site #027

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Vima Site #007

Olney, Maryland, United States

Site Status RECRUITING

Vima Site #002

Farmington Hills, Michigan, United States

Site Status RECRUITING

Vima Site #014

Albuquerque, New Mexico, United States

Site Status RECRUITING

Vima Site #017

Commack, New York, United States

Site Status RECRUITING

Vima Site #018

New York, New York, United States

Site Status NOT_YET_RECRUITING

Vima Site #024

New York, New York, United States

Site Status RECRUITING

Vima Site #029

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

Vima Site #020

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Vima Site #021

Charleston, South Carolina, United States

Site Status NOT_YET_RECRUITING

Vima Site #016

Memphis, Tennessee, United States

Site Status RECRUITING

Vima Site #006

Nashville, Tennessee, United States

Site Status RECRUITING

Vima Site #025

Dallas, Texas, United States

Site Status NOT_YET_RECRUITING

Vima Site #026

Georgetown, Texas, United States

Site Status RECRUITING

Vima Site #012

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Vima Site #011

Richmond, Virginia, United States

Site Status RECRUITING

Vima Site #023

Kirkland, Washington, United States

Site Status NOT_YET_RECRUITING

Vima Site #015

Spokane, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Director

Role: CONTACT

617-430-7027

Facility Contacts

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Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Study Director

Role: primary

617-430-7027

Other Identifiers

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VIM0423-401

Identifier Type: -

Identifier Source: org_study_id

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