Fut, nem toborozFázis nélkül
An Observational Study of Individuals With Isolated Dystonia
A legfontosabb adatok
- Ki végzi
- Vima Therapeutics
- Hol
- Albuquerque, Aliso Viejo, Atlanta, Boca Raton, Charleston, Chicago, Commack, Dallas, Englewood, Farmington Hills, Gainesville, Georgetown, Houston, Kirkland, Los Angeles, Memphis, Miami, Nashville, New York, Olney, Orlando, Palo Alto, Philadelphia, Portland, Richmond, Scottsdale, Spokane és Sun City (Egyesült Államok)Mind a 29 helyszín megnézése
- Azonosító
- Állapot
- Fut, nem toboroz
- Résztvevők
- 200 fő, tervezett
- Kezdés
- 2025. jún. 17.
- Várható befejezés
- 2026. nov.
- A vizsgálat típusa
- Megfigyeléses
- A regiszteradat frissítve
- 2026. november 13.
Ki vehet részt
- Életkor
- 12 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- The participant has had myotomy or denervation surgery in any affected muscles (e.g., peripheral denervation and/or spinal cord stimulation)
- The participant has undergone deep brain stimulation (DBS) surgery (even if implant deactivated)
- 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 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 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 diagnosis of focal dystonia at Visit 1
- The participant has a diagnosis of dopa-responsive dystonia, secondary dystonia, or psychogenic/functional dystonia
Helyszínek itt: Egyesült Államok
- Albuquerque, New MexicoHospital not named in the registryNo longer taking part
- Aliso Viejo, CaliforniaHospital not named in the registryNo longer taking part
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Boca Raton, FloridaHospital not named in the registryNo longer taking part
- Charleston, South CarolinaHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Commack, New YorkHospital not named in the registryNo longer taking part
- Dallas, TexasHospital not named in the registryNo longer taking part
- Englewood, ColoradoHospital not named in the registryNo longer taking part
- Farmington Hills, MichiganHospital not named in the registryNo longer taking part
- Gainesville, FloridaHospital not named in the registryNo longer taking part
- Georgetown, TexasHospital not named in the registryNo longer taking part
- Houston, TexasHospital not named in the registryNo longer taking part
- Kirkland, WashingtonHospital not named in the registryNo longer taking part
- Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
- Memphis, TennesseeHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- Nashville, TennesseeHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Olney, MarylandHospital not named in the registryNo longer taking part
- Orlando, FloridaHospital not named in the registryNo longer taking part
- Palo Alto, CaliforniaHospital not named in the registryNo longer taking part
- Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
- Portland, OregonHospital not named in the registryNo longer taking part
- Richmond, VirginiaHospital not named in the registryNo longer taking part
- Scottsdale, ArizonaHospital not named in the registryNo longer taking part
- Spokane, WashingtonHospital not named in the registryNo longer taking part
- Sun City, ArizonaHospital not named in the registryNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat csoportja
- 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.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. november 13.