Status:
RECRUITING
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D LLC
Conditions:
Multiple System Atrophy
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A ...
Eligibility Criteria
Inclusion
- Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements
- Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit
- Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP
- Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product
- NOTE - Additional criteria apply, please contact the investigator for more information
Exclusion
- Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial
- Is of a vulnerable population (eg, people kept in detention or jail)
- Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial
- Note - Additional criteria apply, please contact the investigator for more information
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 17 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07197866
Start Date
September 30 2025
End Date
May 17 2029
Last Update
December 17 2025
Active Locations (2)
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1
Teva Investigational Site 15544
Boca Raton, Florida, United States, 33486
2
Teva Investigational Site 15543
Spokane, Washington, United States, 99202