CClinicalTrials.gg
RecruitingNCT07197866Updated Sep 14, 2026

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

A Phase 2 interventional study of TEV-56286 in Multiple System Atrophy, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Recruiting at 36 sites in 7 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Teva Branded Pharmaceutical Products R&D LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
30 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple System Atrophy
03

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    TEV-56286

    Drug: TEV-56286

Interventions

  • DrugTEV-56286

    administered orally

    Also known as: Emrusolmin

05

What researchers measure

Primary outcomes

  1. Number of participants experiencing an adverse event

    Time frame: Baseline to Week 100

  2. Number of participants who withdrew from the trial due to an adverse event

    Time frame: Baseline to Week 100

Secondary outcomes

  1. Number of participants with potentially clinically significant vital sign values

    Time frame: Baseline to Week 96

  2. Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)

    Time frame: Baseline to Week 96

  3. Number of participants with potentially clinically significant 12-lead ECG measurements

    Time frame: Baseline to Week 96

06

Study locations

35 of 36 sites recruiting
  • Teva Investigational Site 15554
    La Jolla, California 92037, United States
    Recruiting
  • Teva Investigational Site 15544
    Boca Raton, Florida 33486, United States
    Recruiting
  • Teva Investigational Site 15555
    Tampa, Florida 33613, United States
    Recruiting
  • Teva Investigational Site 15546
    Kansas City, Kansas 66160, United States
    Recruiting
  • Teva Investigational Site 15549
    New York, New York 10016, United States
    Recruiting
  • Teva Investigational Site 15551
    New York, New York 10032-3726, United States
    Recruiting
  • Teva Investigational Site 15548
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
  • Teva Investigational Site 15543
    Spokane, Washington 99202, United States
    Recruiting
  • Teva Investigational Site 35290
    Bordeaux, 33400, France
    Recruiting
  • Teva Investigational Site 35289
    Marseille, 13385, France
    Not yet recruiting
  • Teva Investigational Site 35291
    Paris, 75651, France
    Recruiting
  • Teva Investigational Site 35292
    Toulouse, 31059, France
    Recruiting
  • Teva Investigational Site 32818
    Dresden, 01307, Germany
    Recruiting
  • Teva Investigational Site 32822
    Düsseldorf, 40225, Germany
    Recruiting
  • Teva Investigational Site 32825
    Kassel, 34128, Germany
    Recruiting
  • Teva Investigational Site 32824
    Marburg, 35033, Germany
    Recruiting
  • Teva Investigational Site 32820
    München, 81377, Germany
    Recruiting
  • Teva Investigational Site 32819
    Münster, 48149, Germany
    Recruiting
  • Teva Investigational Site 80203
    Haifa, 31999, Israel
    Recruiting
  • Teva Investigational Site 80204
    Tel Aviv, 6423906, Israel
    Recruiting
  • Teva Investigational Site 30299
    Bologna, 40139, Italy
    Recruiting
  • Teva Investigational Site 30297
    Catania, 95123, Italy
    Recruiting
  • Teva Investigational Site 30298
    Milan, 20132, Italy
    Recruiting
  • Teva Investigational Site 30296
    Roma, 00163, Italy
    Recruiting
  • Teva Investigational Site 30295
    Salerno, 84131, Italy
    Recruiting
  • Teva Investigational Site 84139
    Fuchū, 183-0042, Japan
    Recruiting
  • Teva Investigational Site 84137
    Niigata, 951-8520, Japan
    Recruiting
  • Teva Investigational Site 84138
    Sagamihara, 252-0392, Japan
    Recruiting
  • Teva Investigational Site 84141
    Sanda-shi, 669-1592, Japan
    Recruiting
  • Teva Investigational Site 84135
    Sendai, 982-8555, Japan
    Recruiting
  • Teva Investigational Site 31324
    Barcelona, 08025, Spain
    Recruiting
  • Teva Investigational Site 31323
    Barcelona, 08035, Spain
    Recruiting
  • Teva Investigational Site 31321
    Barcelona, 08036, Spain
    Recruiting
  • Teva Investigational Site 31320
    Pamplona, 31008, Spain
    Recruiting
  • Teva Investigational Site 31322
    Seville, 41013, Spain
    Recruiting
  • Teva Investigational Site 31319
    Valencia, 46026, Spain
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07197866
Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Sep 30, 2025
Primary completion
May 3, 2029 (estimated)
Completion
May 17, 2029 (estimated)
Last update
Sep 14, 2026

Study contacts

Teva U.S. Medical Information
Contact
USMedInfo@tevapharm.com
1-888-483-8279
Teva Medical Expert, MD
study director · Teva Branded Pharmaceutical Products R&D LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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