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NCT Number: NCT07197866

An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).

A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.

The planned total duration of the trial is approximately 100 weeks.

Recruiting

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Teva Investigational Site 35290, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements
  • Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit
  • Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP
  • Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product

NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion criteria

  • Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial
  • Is of a vulnerable population (eg, people kept in detention or jail)
  • Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial

Note - Additional criteria apply, please contact the investigator for more information

Treatment and study plan

TEV-56286

Drug

administered orally

Other names: Emrusolmin

Primary outcomes

  1. Number of participants experiencing an adverse event

    Time frame: Baseline to Week 100

  2. Number of participants who withdrew from the trial due to an adverse event

    Time frame: Baseline to Week 100

Secondary outcomes

  1. Number of participants with potentially clinically significant vital sign values

    Time frame: Baseline to Week 96

  2. Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)

    Time frame: Baseline to Week 96

  3. Number of participants with potentially clinically significant 12-lead ECG measurements

    Time frame: Baseline to Week 96

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

An Open-Label Extension, Multi-Centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants With Multiple System Atrophy

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 29, 2025
Registry last updated
Jul 27, 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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