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

NCT06568237 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: TV56286-NDG-200392023-505320-54-00
• Study Type: interventional
• Target: 350
• Locations: 7 countries
• Sites: 58

Brief 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.

Conditions

Multiple System Atrophy

Keywords

Multiple System Atrophy (MSA)

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline to Week 48

• For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined

  The UMSARS is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).

  Baseline to Week 48

Secondary Outcomes (19)

• For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)

  Baseline to Week 48

• For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3)

  Baseline to Week 48

• Change From Baseline in the UMSARS Part 1 Score

  Baseline to Week 48

• Change From Baseline in Lateral Ventricle Volume Measured by MRI

  Baseline to Week 48

• Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S)

  Baseline to Week 48

Study Arms (2)

TEV-56286

EXPERIMENTAL

Orally administered capsules once daily

Drug: TEV-56286

Placebo

PLACEBO COMPARATOR

Orally administered capsules once daily

Drug: Placebo

Interventions

TEV-56286 DRUG

TEV-56286 capsules administered orally

Also known as: emrusolmin, anle138b

TEV-56286

Placebo DRUG

Matching placebo administered orally

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Additional criteria apply; please contact the investigator for more information

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (58)

Teva Investigational Site 15554

La Jolla, California, 92037, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15545

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Teva Investigational Site 15547

Washington D.C., District of Columbia, 20007, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15544

Boca Raton, Florida, 33486, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15555

Tampa, Florida, 33613, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15550

Chicago, Illinois, 60612-3852, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15546

Kansas City, Kansas, 66160, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15736

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15870

Farmington Hills, Michigan, 48334, United States

NOT YET RECRUITING

Teva Investigational Site 15552

Rochester, Minnesota, 55905, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15549

New York, New York, 10016, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15551

New York, New York, 10032-3726, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15553

Durham, North Carolina, 27705-4410, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15735

Hershey, Pennsylvania, 17033, United States

NOT YET RECRUITING

Teva Investigational Site 15548

Pittsburgh, Pennsylvania, 15213, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15874

Nashville, Tennessee, 37212, United States

RECRUITING

Teva Investigational Site 15869

Georgetown, Texas, 78628, United States

NOT YET RECRUITING

Teva Investigational Site 15873

Alexandria, Virginia, 22310, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 15543

Spokane, Washington, 99202, United States

ACTIVE NOT RECRUITING

Teva Investigational Site 35290

Bordeaux, 33400, France

ACTIVE NOT RECRUITING

Teva Investigational Site 35300

Caen, 14033, France

RECRUITING

Teva Investigational Site 35289

Marseille, 13385, France

ACTIVE NOT RECRUITING

Teva Investigational Site 35291

Salpêtrière, 75651 Paris Ced, France

ACTIVE NOT RECRUITING

Teva Investigational Site 35292

Toulouse, 31059, France

ACTIVE NOT RECRUITING

Teva Investigational Site 32823

Beelitz-Heilstätten, 14547, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 32818

Dresden, 01307, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 32822

Düsseldorf, 40225, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 32825

Kassel, 34128, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 32826

Leipzig, 04103, Germany

RECRUITING

Teva Investigational Site 32824

Marburg, 35033, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 32820

München, 81377, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 32819

Münster, 48149, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 32821

Ulm, 89081, Germany

ACTIVE NOT RECRUITING

Teva Investigational Site 80203

Haifa, 31999, Israel

ACTIVE NOT RECRUITING

Teva Investigational Site 80215

Jerusalem, 9103102, Israel

ACTIVE NOT RECRUITING

Teva Investigational Site 80204

Tel Aviv, 6423906, Israel

ACTIVE NOT RECRUITING

Teva Investigational Site 30299

Bologna, 40139, Italy

ACTIVE NOT RECRUITING

Teva Investigational Site 30297

Catania, 95123, Italy

ACTIVE NOT RECRUITING

Teva Investigational Site 30298

Milan, 20132, Italy

ACTIVE NOT RECRUITING

Teva Investigational Site 30294

Padova, 35127, Italy

ACTIVE NOT RECRUITING

Teva Investigational Site 30296

Roma, 00163, Italy

ACTIVE NOT RECRUITING

Teva Investigational Site 30295

Salerno, 84131, Italy

ACTIVE NOT RECRUITING

Teva Investigational Site 84140

Chiba, 260-8677, Japan

ACTIVE NOT RECRUITING

Teva Investigational Site 84139

Fuchū, 183-0042, Japan

ACTIVE NOT RECRUITING

Teva Investigational Site 84136

Gifu, 501-1112, Japan

ACTIVE NOT RECRUITING

Teva Investigational Site 84137

Niigata, 951-8520, Japan

ACTIVE NOT RECRUITING

Teva Investigational Site 84138

Sagamihara, 252-0392, Japan

ACTIVE NOT RECRUITING

Teva Investigational Site 84141

Sanda-shi, 669-1592, Japan

ACTIVE NOT RECRUITING

Teva Investigational Site 84135

Sendai, 982-8555, Japan

ACTIVE NOT RECRUITING

Teva Investigational Site 31328

Barakaldo, 48903, Spain

RECRUITING

Teva Investigational Site 31323

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

Teva Investigational Site 31321

Barcelona, 08036, Spain

ACTIVE NOT RECRUITING

Teva Investigational Site 31324

Barcelona, 08041, Spain

ACTIVE NOT RECRUITING

Teva Investigational Site 31327

Madrid, 28006, Spain

ACTIVE NOT RECRUITING

Teva Investigational Site 31331

Madrid, 28041, Spain

RECRUITING

Teva Investigational Site 31320

Pamplona, 31008, Spain

ACTIVE NOT RECRUITING

Teva Investigational Site 31322

Seville, 41015, Spain

ACTIVE NOT RECRUITING

Teva Investigational Site 31319

Valencia, 46026, Spain

ACTIVE NOT RECRUITING

Related Links

• Teva MSA Trial
• TOPAS-MSA Web Site
• Teva MSA Trial EU Locations

MeSH Terms

Conditions

Multiple System Atrophy

Interventions

3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Tev Medical Expert, Study Director

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Central Study Contacts

Teva U.S. Medical Information

CONTACT

1-888-483-8279; USMedInfo@tevapharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (9); US (19); IT (6); JP (7); ES (9); IL (3); FR (5)