Recruiting

Observational Study

Sponsor:

Vima Therapeutics

Code:

NCT07111663

Conditions

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

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07111663

Start date

Jun 17, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Burke-Fahn-Marsden (BFM) Dystonia Rating Scale [ Time Frame: From start of treatment through 4 months ]

Central Contacts and Locations

Central contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Locations

Vima Site #028

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #030

Recruiting

Los Angeles, California, United States, 97239

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #027

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #018

Recruiting

New York, New York, United States, 10029

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #029

Recruiting

Portland, Oregon, United States, 97239

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #021

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #025

Recruiting

Dallas, Texas, United States, 75390

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #012

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

Vima Site #023

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Study Director

617-430-7027clinicaltrials@vimatx.com

More Information

Sponsor

Vima Therapeutics

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Dystonia, Isolated Dystonia, Primary Dystonia, Cervical Dystonia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vima Therapeutics on 2026-08-19.