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Taking people in United StatesPhase 2

Long-term safety of TEV-56286 taken by mouth in multiple system atrophy

Looks at long-term safety of TEV-56286 in adults with multiple system atrophy.

Key facts

Who runs it
Teva Branded Pharmaceutical Products R&D LLC
Where
Boca Raton, Chicago, Durham, Kansas City, La Jolla, New York, Pittsburgh, Spokane, and Tampa, United StatesSee the 10 sitesAlso in 6 other countries, 36 sites
Registry title
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
Status
Recruiting
Phase
Phase 2
People taking part
200 people, planned
Started
30 Sept 2025
Expected to end
17 May 2029
Type of study
Interventional
Treatments tested
  • TEV-56286
Record updated
9 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Multiple System Atrophy (MSA) who finished the earlier double-blind trial TV56286-NDG-20039. They will take TEV-56286 by mouth over a longer period.

Age
30 years and older
Sex
All sexes
Disease stage
Multiple System Atrophy (MSA)
Earlier treatment
People must have completed the treatment period and the week 48 (V9) visit of the double-blind trial TV56286-NDG-20039, while following its rules.

Main reasons for not taking part

  • Being pregnant, planning to become pregnant, or breastfeeding during the trial
  • Belonging to a vulnerable group, such as people in detention or jail
  • Using medicines not allowed by the trial within the set time windows
  • Women who could become pregnant without a negative pregnancy test at the first visit
  • Not using highly effective birth control during the trial and for 28 days after the last dose

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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)

Where in United States

Also in 6 other countries, 36 sites

  • Boca Raton, FloridaHospital not named in the registryTaking people
  • Chicago, IllinoisHospital not named in the registryTaking people
  • Durham, North CarolinaHospital not named in the registryTaking people
  • Kansas City, KansasHospital not named in the registryTaking people
  • La Jolla, CaliforniaHospital not named in the registryTaking people
  • New YorkHospital not named in the registryTaking people
  • New YorkHospital not named in the registryTaking people
  • Pittsburgh, PennsylvaniaHospital not named in the registryTaking people
  • Spokane, WashingtonHospital not named in the registryTaking people
  • Tampa, FloridaHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The group in the trial

  • TEV-56286Treatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Long-term safety of TEV-56286 taken by mouth in multiple system atrophyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
9 October 2026