An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEV-56286.
- Who it may be relevant to
- Registry conditions: Multiple System Atrophy. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Germany, Israel, Italy +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Drug TEV-56286
administered orally
Primary outcome measures
- Number of participants experiencing an adverse event [Time frame: Baseline to Week 100]
- Number of participants who withdrew from the trial due to an adverse event [Time frame: Baseline to Week 100]
Secondary outcome measures (3)
- Number of participants with potentially clinically significant vital sign values [Time frame: Baseline to Week 96]
- Number of participants with potentially clinically significant laboratory test values (hematology and chemistry) [Time frame: Baseline to Week 96]
- Number of participants with potentially clinically significant 12-lead ECG measurements [Time frame: Baseline to Week 96]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Teva Investigational Site 15554 — La Jolla
- Teva Investigational Site 15544 — Boca Raton
- Teva Investigational Site 15555 — Tampa
- Teva Investigational Site 15549 — New York
- Teva Investigational Site 15551 — New York
- Teva Investigational Site 15548 — Pittsburgh
- Teva Investigational Site 15543 — Spokane
Germany · 6 centers
- Teva Investigational Site 32818 — Dresden
- Teva Investigational Site 32822 — Düsseldorf
- Teva Investigational Site 32825 — Kassel
- Teva Investigational Site 32824 — Marburg
- Teva Investigational Site 32820 — München
- Teva Investigational Site 32819 — Münster
Spain · 6 centers
- Teva Investigational Site 31324 — Barcelona
- Teva Investigational Site 31323 — Barcelona
- Teva Investigational Site 31321 — Barcelona
- Teva Investigational Site 31320 — Pamplona
- Teva Investigational Site 31322 — Seville
- Teva Investigational Site 31319 — Valencia
Italy · 4 centers
- Teva Investigational Site 30299 — Bologna
- Teva Investigational Site 30298 — Milan
- Teva Investigational Site 30296 — Roma
- Teva Investigational Site 30295 — Salerno
Japan · 4 centers
- Teva Investigational Site 84137 — Niigata
- Teva Investigational Site 84138 — Sagamihara
- Teva Investigational Site 84141 — Sanda-shi
- Teva Investigational Site 84135 — Sendai
France · 3 centers
- Teva Investigational Site 35290 — Bordeaux
- Teva Investigational Site 35291 — Paris
- Teva Investigational Site 35292 — Toulouse
Israel · 2 centers
- Teva Investigational Site 80203 — Haifa
- Teva Investigational Site 80204 — Tel Aviv
Identifiers
NCT: NCT07197866 · TV56286-NDG-20041 · 2025-521642-14-00