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

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 (TOPAS-MSA)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple System Atrophy
• Intervention / Treatment: Drug: Placebo; Drug: TEV-56286

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Teva U.S. Medical Information; Phone Number: 1-888-483-8279; Email: USMedInfo@tevapharm.com

Study Locations

• France
  • Bordeaux, France, 33400
    • Active, not recruiting
    • Teva Investigational Site 35290
  • Marseille, France, 13385
    • Active, not recruiting
    • Teva Investigational Site 35289
  • Salpêtrière, France, 75651 Paris Ced
    • Active, not recruiting
    • Teva Investigational Site 35291
  • Toulouse, France, 31059
    • Active, not recruiting
    • Teva Investigational Site 35292
• Germany
  • Beelitz-Heilstätten, Germany, 14547
    • Active, not recruiting
    • Teva Investigational Site 32823
  • Dresden, Germany, 01307
    • Active, not recruiting
    • Teva Investigational Site 32818
  • Düsseldorf, Germany, 40225
    • Active, not recruiting
    • Teva Investigational Site 32822
  • Kassel, Germany, 34128
    • Active, not recruiting
    • Teva Investigational Site 32825
  • Leipzig, Germany, 04103
    • Recruiting
    • Teva Investigational Site 32826
  • Marburg, Germany, 35033
    • Active, not recruiting
    • Teva Investigational Site 32824
  • München, Germany, 81377
    • Active, not recruiting
    • Teva Investigational Site 32820
  • Münster, Germany, 48149
    • Active, not recruiting
    • Teva Investigational Site 32819
  • Ulm, Germany, 89081
    • Active, not recruiting
    • Teva Investigational Site 32821
• Israel
  • Haifa, Israel, 31999
    • Active, not recruiting
    • Teva Investigational Site 80203
  • Jerusalem, Israel, 9103102
    • Active, not recruiting
    • Teva Investigational Site 80215
  • Tel Aviv, Israel, 6423906
    • Active, not recruiting
    • Teva Investigational Site 80204
• Italy
  • Bologna, Italy, 40139
    • Active, not recruiting
    • Teva Investigational Site 30299
  • Catania, Italy, 95123
    • Active, not recruiting
    • Teva Investigational Site 30297
  • Milan, Italy, 20132
    • Active, not recruiting
    • Teva Investigational Site 30298
  • Padova, Italy, 35127
    • Active, not recruiting
    • Teva Investigational Site 30294
  • Roma, Italy, 00163
    • Active, not recruiting
    • Teva Investigational Site 30296
  • Salerno, Italy, 84131
    • Active, not recruiting
    • Teva Investigational Site 30295
• Japan
  • Chiba, Japan, 260-8677
    • Active, not recruiting
    • Teva Investigational Site 84140
  • Fuchū, Japan, 183-0042
    • Active, not recruiting
    • Teva Investigational Site 84139
  • Gifu, Japan, 501-1112
    • Active, not recruiting
    • Teva Investigational Site 84136
  • Niigata, Japan, 951-8520
    • Active, not recruiting
    • Teva Investigational Site 84137
  • Sagamihara, Japan, 252-0392
    • Active, not recruiting
    • Teva Investigational Site 84138
  • Sanda-shi, Japan, 669-1592
    • Active, not recruiting
    • Teva Investigational Site 84141
  • Sendai, Japan, 982-8555
    • Active, not recruiting
    • Teva Investigational Site 84135
• Spain
  • Barcelona, Spain, 08041
    • Active, not recruiting
    • Teva Investigational Site 31324
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Teva Investigational Site 31323
  • Barcelona, Spain, 08036
    • Active, not recruiting
    • Teva Investigational Site 31321
  • Madrid, Spain, 28006
    • Active, not recruiting
    • Teva Investigational Site 31327
  • Pamplona, Spain, 31008
    • Active, not recruiting
    • Teva Investigational Site 31320
  • Seville, Spain, 41015
    • Active, not recruiting
    • Teva Investigational Site 31322
  • Valencia, Spain, 46026
    • Active, not recruiting
    • Teva Investigational Site 31319
• United States
  • California
    • La Jolla, California, United States, 92037
      • Active, not recruiting
      • Teva Investigational Site 15554
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • Teva Investigational Site 15545
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Active, not recruiting
      • Teva Investigational Site 15547
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Active, not recruiting
      • Teva Investigational Site 15544
    • Tampa, Florida, United States, 33613
      • Active, not recruiting
      • Teva Investigational Site 15555
  • Illinois
    • Chicago, Illinois, United States, 60612-3852
      • Active, not recruiting
      • Teva Investigational Site 15550
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Active, not recruiting
      • Teva Investigational Site 15546
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Active, not recruiting
      • Teva Investigational Site 15736
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Not yet recruiting
      • Teva Investigational Site 15870
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Active, not recruiting
      • Teva Investigational Site 15552
  • New York
    • New York, New York, United States, 10016
      • Active, not recruiting
      • Teva Investigational Site 15549
    • New York, New York, United States, 10032-3726
      • Active, not recruiting
      • Teva Investigational Site 15551
  • North Carolina
    • Durham, North Carolina, United States, 27705-4410
      • Active, not recruiting
      • Teva Investigational Site 15553
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Not yet recruiting
      • Teva Investigational Site 15735
    • Pittsburgh, Pennsylvania, United States, 15213
      • Active, not recruiting
      • Teva Investigational Site 15548
  • Texas
    • Georgetown, Texas, United States, 78628
      • Not yet recruiting
      • Teva Investigational Site 15869
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Active, not recruiting
      • Teva Investigational Site 15873
  • Washington
    • Spokane, Washington, United States, 99202
      • Active, not recruiting
      • Teva Investigational Site 15543

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)		Up to Week 48
Number of Participants Who Withdraw From the Study Due to an Adverse Event		Up to Week 48
Number of Participants Who Withdraw From Treatment Due to an Adverse Event		Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value		Up to Week 48
Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value		Up to Week 48
Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings		Up to Week 48
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)	The CGI-S scale permits a global evaluation of the participant's current severity of illness on a Likert type scale ranging from 1 to 7, where 1=normal/not at all ill, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill participants	Baseline to Week 48
Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)		Baseline to Week 48
Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S)	The PGI-S scale permits an evaluation of the participant's MSA severity, according to the participant. The PGI-S scale rates the participant's MSA severity on a 5-point Likert type scale ranging from 0 (not severe) to 4 (very severe)	Baseline to Week 48
Change From Baseline in the Pons volume measured by MRI		Baseline to Week 48
Change From Baseline in the Cerebellar volume measured by MRI		Baseline to Week 48
Change From Baseline in the UMSARS part II score		Baseline to Week 48
Change From Baseline in the UMSARS part IV score		Baseline to Week 48
Change From Baseline in the Two-minute walk test as part of gait assessment		Baseline to Week 48
Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score	The 40-item MSA-QoL questionnaire is self-administered and each item is rated on a Likert type scale (0: No problem) to (4: Extreme problem). It is comprised of 3 subscales relevant to MSA: motor (14 items), non-motor (12 items), and emotional/social (14 items). The MSA-QoL total score is the sum of all the items and lower scores indicate better QoL.	Baseline to Week 48

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D LLC
• Investigators: Study Director: Tev Medical Expert, Study Director, Teva Branded Pharmaceutical Products R&D LLC

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Multiple System Atrophy (MSA)
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Multiple System Atrophy; Substandard Drugs; Pharmaceutical Preparations; 3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole
• Other Study ID Numbers: TV56286-NDG-20039; 2023-505320-54-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No