An Observational Study of Individuals With Isolated Dystonia

Conditions

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

Eligibility Criteria

Sex

ALL

Age

12 Years - 65 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Jun 17, 2025

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: 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

• Study Director
  617-430-7027
  [email protected]

Locations (29)

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