臨床研究等提出・公開システム

A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy

A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study

Masutani Hiroshi

A2 Healthcare Corporation

Sumitomo Fudosan Korakuen Bldg, 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

tev-56286_trialinfomation@a2healthcare.com

Masutani Hiroshi

A2 Healthcare Corporation

Sumitomo Fudosan Korakuen Bldg, 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

+81-3-3830-1173

tev-56286_trialinfomation@a2healthcare.com

Not Recruiting

April. 10, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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

Both

Multiple System Atrophy

TEV-56286 orally once daily for 48 weeks.

Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score
The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes 11 items and item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).

+81-22-245-2111

Dec. 23, 2024

No

US/Israel/Italy/Spain/Germany/France/Serbia