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

Purpose

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.

Condition

  • Multiple System Atrophy

Eligibility

Eligible Ages
Over 30 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TEV-56286 		Orally administered capsules once daily
  • Drug: TEV-56286
    TEV-56286 capsules administered orally
    Other names:
    • emrusolmin, anle138b
Placebo Comparator
Placebo 		Orally administered capsules once daily
  • Drug: Placebo
    Matching placebo administered orally

Recruiting Locations

Teva Investigational Site 15554
La Jolla, California 92037

Teva Investigational Site 15547
Washington, District of Columbia 20007

Teva Investigational Site 15544
Boca Raton, Florida 33486

Teva Investigational Site 15555
Tampa, Florida 33063

Teva Investigational Site 15546
Kansas City, Kansas 66160

Teva Investigational Site 15736
Boston, Massachusetts 02115

Teva Investigational Site 15552
Rochester, Minnesota 55905

Teva Investigational Site 15549
New York, New York 10016

Teva Investigational Site 15551
New York, New York 10032-3726

Teva Investigational Site 15553
Durham, North Carolina 27705-4410

Teva Investigational Site 15735
Hershey, Pennsylvania 17033

Teva Investigational Site 15543
Spokane, Washington 99202

More Details

NCT ID
NCT06568237
Status
Recruiting
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

Study Contact

Teva U.S. Medical Information
1-888-483-8279
USMedInfo@tevapharm.com

Detailed Description

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center