An Extension Trial for TEV-56286 in Multiple System Atrophy

This study is an extension trial testing TEV-56286, an oral medication, for adults with Multiple System Atrophy (MSA). The main goal is to understand the long-term safety and how well people tolerate TEV-56286 over about 100 weeks. You can join if you've already completed a previous trial (TV56286-NDG-20039) and met its requirements. For women who could become pregnant, a negative pregnancy test is needed. This trial is looking to enroll 200 participants. We'll know the study is successful if we can describe the long-term safety and tolerability of TEV-56286, including how many people experience side effects or leave the study because of them.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 200 participants.
What's involved
You would take TEV-56286 orally for approximately 100 weeks. You must have completed a previous trial (TV56286-NDG-20039) and its requirements.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and withdrawals from Baseline to Week 100.

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NCT07197866

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

Recruiting
PHASE2Ages 30+InterventionalTreatment
Teva Branded Pharmaceutical Products R&D LLC
~200 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:TEV-56286

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing an adverse event
Measured over Baseline to Week 100
+1 more outcome measured
Multiple System Atrophy
32 sites across 11 states
Germany6
Spain6
Italy4
Japan4
France3
Florida2
New York2
Israel2
  • Teva Medical Expert, MD · STUDY_DIRECTOR · Teva Branded Pharmaceutical Products R&D LLC

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Number of participants experiencing an adverse eventBaseline to Week 100
  • Number of participants who withdrew from the trial due to an adverse eventBaseline to Week 100