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NCT Number: NCT06568237

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

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.

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Key information

Conditions

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

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Teva Investigational Site 35290, Bordeaux, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEV-56286

Drug

TEV-56286 capsules administered orally

Other names: emrusolmin, anle138b

Placebo

Drug

Matching placebo administered orally

Primary outcomes

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

    Time frame: Baseline to Week 48

    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).

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

    Time frame: Baseline to Week 48

    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).

Secondary outcomes

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

    Time frame: Baseline to Week 48

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

    Time frame: Baseline to Week 48

  3. Change From Baseline in the UMSARS Part 1 Score

    Time frame: Baseline to Week 48

  4. Change From Baseline in Lateral Ventricle Volume Measured by MRI

    Time frame: Baseline to Week 48

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

    Time frame: Baseline to Week 48

    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

  6. Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF)

    Time frame: Baseline to Week 48

  7. Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S)

    Time frame: Baseline to Week 48

    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)

  8. Change From Baseline in the Pons volume measured by MRI

    Time frame: Baseline to Week 48

  9. Change From Baseline in the Cerebellar volume measured by MRI

    Time frame: Baseline to Week 48

  10. Change From Baseline in the UMSARS part II score

    Time frame: Baseline to Week 48

  11. Change From Baseline in the UMSARS part IV score

    Time frame: Baseline to Week 48

  12. Change From Baseline in the Two-minute walk test as part of gait assessment

    Time frame: Baseline to Week 48

  13. Change From Baseline in the Multiple System Atrophy - Quality of Life (MSA-QoL) Score

    Time frame: Baseline to Week 48

    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.

  14. Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAEs)

    Time frame: Up to Week 48

  15. Number of Participants Who Withdraw From the Study Due to an Adverse Event

    Time frame: Up to Week 48

  16. Number of Participants Who Withdraw From Treatment Due to an Adverse Event

    Time frame: Up to Week 48

  17. Number of Participants With At Least One Potentially Clinically Significant Abnormal Vital Sign Value

    Time frame: Up to Week 48

  18. Number of Participants With At Least One Potentially Clinically Significant Laboratory Test Value

    Time frame: Up to Week 48

  19. Number of Participants with at Least One Potentially Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings

    Time frame: Up to Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

Teva U.S. Medical Information

CONTACT

[email protected]

1-888-483-8279

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC

Industry

Registry information

Official study title

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)

Acronym: TOPAS-MSA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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