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 secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.
The planned total duration of the trial is approximately 100 weeks.
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
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
Single group
TEV-56286
Drugadministered orally
Number of participants experiencing an adverse event
Number of participants who withdrew from the trial due to an adverse event
Number of participants with potentially clinically significant vital sign values
Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)
Number of participants with potentially clinically significant 12-lead ECG measurements
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