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NCT06568237
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Conditions: Multiple System Atrophy
Sex: All
Ages: 30 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 350
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Location: Teva Investigational Site 15554 La Jolla California
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 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.
Eligibility Criteria
Inclusion Criteria:
* 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 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
Source: ClinicalTrials.gov (NCT06568237). StuddyBuddy aggregates publicly available trial information.
