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
2 other identifiers
interventional
200
7 countries
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2025
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2025
CompletedFirst Posted
Study publicly available on registry
September 29, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 17, 2029
May 4, 2026
April 1, 2026
3.6 years
September 26, 2025
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants experiencing an adverse event
Baseline to Week 100
Number of participants who withdrew from the trial due to an adverse event
Baseline to Week 100
Secondary Outcomes (3)
Number of participants with potentially clinically significant vital sign values
Baseline to Week 96
Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)
Baseline to Week 96
Number of participants with potentially clinically significant 12-lead ECG measurements
Baseline to Week 96
Study Arms (1)
TEV-56286
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Note - Additional criteria apply, please contact the investigator for more information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Teva Investigational Site 15544
Boca Raton, Florida, 33486, United States
Teva Investigational Site 15555
Tampa, Florida, 33613, United States
Teva Investigational Site 15549
New York, New York, 10016, United States
Teva Investigational Site 15551
New York, New York, 10032-3726, United States
Teva Investigational Site 15543
Spokane, Washington, 99202, United States
Teva Investigational Site 35290
Bordeaux, 33400, France
Teva Investigational Site 35291
Paris, 75651, France
Teva Investigational Site 35292
Toulouse, 31059, France
Teva Investigational Site 32818
Dresden, 01307, Germany
Teva Investigational Site 80203
Haifa, 31999, Israel
Teva Investigational Site 30299
Bologna, 40139, Italy
Teva Investigational Site 30295
Salerno, 84131, Italy
Teva Investigational Site 84137
Niigata, 951-8520, Japan
Teva Investigational Site 84141
Sanda-shi, 669-1592, Japan
Teva Investigational Site 31324
Barcelona, 08025, Spain
Teva Investigational Site 31323
Barcelona, 08035, Spain
Teva Investigational Site 31322
Seville, 41015, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Teva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2025
First Posted
September 29, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
May 3, 2029
Study Completion (Estimated)
May 17, 2029
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.