Status:
RECRUITING
A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D LLC
Conditions:
Multiple System Atrophy
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan
Eligibility Criteria
Inclusion
- 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
Exclusion
- has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA
- 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
- is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
- has a known hypersensitivity to any components of the IMP
- is of a vulnerable population (eg, people kept in detention or jail)
- 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
Key Trial Info
Start Date :
October 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 17 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06568237
Start Date
October 2 2024
End Date
June 17 2027
Last Update
December 22 2025
Active Locations (52)
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1
Teva Investigational Site 15554
La Jolla, California, United States, 92037
2
Teva Investigational Site 15545
Los Angeles, California, United States, 90095
3
Teva Investigational Site 15547
Washington D.C., District of Columbia, United States, 20007
4
Teva Investigational Site 15544
Boca Raton, Florida, United States, 33486