Overview
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.
Description
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan
Eligibility
Inclusion Criteria:
- is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
- is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed
- 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 Criteria:
- 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