A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
A legfontosabb adatok
- Hol
- Alexandria, Boca Raton, Boston, Chicago, Durham, Farmington Hills, Georgetown, Hershey, Kansas City, La Jolla, Los Angeles, Nashville, New York, Pittsburgh, Rochester, Spokane, Tampa és Washington D.C. (Egyesült Államok)Mind a 19 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Integrated Neurology ServicesAlexandria, Egyesült ÁllamokNo longer taking part
- Parkinson's Disease and Movement Disorder Center of Boca RatonBoca Raton, Egyesült ÁllamokNo longer taking part
- Brigham and Women's HospitalBoston, Egyesült ÁllamokNo longer taking part
- Rush University Medical Center-Allergy/ Immunology CenterChicago, Egyesült ÁllamokNo longer taking part
- Duke University School of Medicine - Duke Neurological Disorders Clinic - Morreene Road LocationDurham, Egyesült ÁllamokNo longer taking part
- Detroit Clinical Research Center, PCFarmington Hills, Egyesült ÁllamokNo longer taking part
- Texas Movement Disorder SpecialistsGeorgetown, Egyesült ÁllamokNo longer taking part
- Penn State Milton S. Hershey Medical CenterHershey, Egyesült ÁllamokNo longer taking part
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
- University of California San DiegoLa Jolla, Egyesült ÁllamokNo longer taking part
- University California Los Angeles Medical Center (Ucla)Los Angeles, Egyesült ÁllamokNo longer taking part
- Vanderbilt University Medical Center (VUMC)Nashville, Egyesült ÁllamokNo longer taking part
- Columbia University Medical Center The Neurological Institute of New YorkNew York, Egyesült ÁllamokNo longer taking part
- NYU Medical Center - Dysautonomia centerNew York, Egyesült ÁllamokNo longer taking part
- University of PittsburghPittsburgh, Egyesült ÁllamokNo longer taking part
- Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
- Inland Northwest ResearchSpokane, Egyesült ÁllamokNo longer taking part
- University of South Florida Parkinson's Disease and Movement Disorders CenterTampa, Egyesült ÁllamokNo longer taking part
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)Washington D.C., Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Teva Branded Pharmaceutical Products R&D LLC
- Azonosító
- NCT06568237EU 2023-505320-54-00
- A regiszteradat frissítve
- 2026. november 5.
- Eredeti leírás
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).A teljes eredeti leírásKevesebb
A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).
A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286.
Another secondary objective is to evaluate the safety and tolerability of TEV-56286.
The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.
Bevonási feltételek: is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria; is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination; Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits; Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods; Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods; Additional criteria apply; please contact the investigator for more information.
Kizáró feltételek: has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening; has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening; participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study; Additional criteria apply; please contact the investigator for more information; has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA; has a known hypersensitivity to any components of the IMP; is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study; is of a vulnerable population (eg, people kept in detention or jail).