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An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Multiple System Atrophy
Date of first enrollment	14/05/2026
Target sample size	23
Countries of recruitment	US,Japan,Germany,Japan,Israel,Japan,Spain,Japan,France,Japan,Italy,Japan
Study type	Interventional
Intervention(s)	TEV-56286 orally once daily for 96 weeks.

Outcome(s)

Primary Outcome	Number of participants experiencing an adverse event Number of participants who withdrew from the trial due to an adverse event
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 30age old
Age maximum	Not applicable
Gender	Both
Include criteria	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
Exclude criteria	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