ClinicalTrials.gov record NCT07197866
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an open-label, single-group Phase 2 extension study of oral TEV-56286 (Emrusolmin) in people with Multiple System Atrophy. It aims to describe long-term safety and tolerability over about 100 weeks. Participants are adults who completed the treatment period and the Week 48 visit of the prior double-blind trial (TV56286-NDG-20039).
What it is studying. Tests the long-term safety and tolerability of oral TEV-56286 in adults with Multiple System Atrophy. Safety is assessed by tracking adverse events, withdrawals due to adverse events, vital signs, laboratory tests (hematology and chemistry), and 12-lead ECGs over the study period (up to about 100 weeks).
What the researchers hope to learn. To describe the long-term safety and tolerability profile of TEV-56286 in people with Multiple System Atrophy and to collect data on adverse events, withdrawals, vital signs, laboratory abnormalities, and ECG findings.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- TEV-56286
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants continue taking TEV-56286 (Emrusolmin) by mouth in an open‑label extension and are followed for about 100 weeks. They will attend regular study visits for safety monitoring, report any side effects, and have checks such as vital signs, blood tests (hematology and chemistry), and 12‑lead ECGs; eligible females will have a pregnancy test at baseline. The study will record adverse events and withdrawals due to adverse events; participants must follow the trial's contraception rules. Additional inclusion/exclusion details and any extra tests or visits are available from the study investigator.
How the study is structured. Open-label (no blinding), single-group Phase 2 extension. All participants receive oral TEV-56286 and are followed for safety assessments for approximately 100 weeks. There is no randomization or placebo group.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in France, Germany, Israel, Italy, Japan, Spain, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Sep 30, 2025
- Primary completion
- May 3, 2029 (estimated)
- Study completion
- May 17, 2029 (estimated)
- Target enrollment
- 200 participants (estimated)
- Last updated on registry
- Oct 9, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Teva U.S. Medical Information 📞 1-888-483-8279 ✉ USMedInfo@tevapharm.com
Participating sites (41)
- Teva Investigational Site 15554Recruiting
La Jolla, California, 92037 · United States
- Teva Investigational Site 15544Recruiting
Boca Raton, Florida, 33486 · United States
- Teva Investigational Site 15555Recruiting
Tampa, Florida, 33613 · United States
- Teva Investigational Site 15550Recruiting
Chicago, Illinois, 60612-3852 · United States
- Teva Investigational Site 15546Recruiting
Kansas City, Kansas, 66160 · United States
- Teva Investigational Site 15549Recruiting
New York, New York, 10016 · United States
- Teva Investigational Site 15551Recruiting
New York, New York, 10032-3726 · United States
- Teva Investigational Site 15553Recruiting
Durham, North Carolina, 27705-4410 · United States
- Teva Investigational Site 15548Recruiting
Pittsburgh, Pennsylvania, 15213 · United States
- Teva Investigational Site 15543Recruiting
Spokane, Washington, 99202 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- secondary objective
- An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.
- double-blind
- Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- prohibited concomitant
- A medicine that participants may not use during the study, usually because it could interfere with the study treatment or its measurement.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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