A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

Phase 2RecruitingNCT06568237

Teva Branded Pharmaceutical Products R&D LLC350 enrolled

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.

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

350

Conditions

Multiple System Atrophy

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (61)

Teva Investigational Site 15554

La Jolla, California, United States

RECRUITING

Teva Investigational Site 15545

Los Angeles, California, United States

NOT_YET_RECRUITING

Teva Investigational Site 15547

Washington D.C., District of Columbia, United States

RECRUITING

Teva Investigational Site 15544

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)

The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes all items with the exclusion of item 11. Item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).