What this study is
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.
What's being tested
- TEV-56286
Intervention · DRUG
administered orally
Study details
- 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
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Conditions
- Multiple System Atrophy
- Enrolling
- 200 people
- Starts
- 2025-09-30
- Est. completion
- 2029-05-17
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 30 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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)
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (41)
41 openTeva Investigational Site 15554
La Jolla, California, United States
RecruitingTeva Investigational Site 15544
Boca Raton, Florida, United States
RecruitingTeva Investigational Site 15555
Tampa, Florida, United States
RecruitingTeva Investigational Site 15550
Chicago, Illinois, United States
RecruitingTeva Investigational Site 15546
Kansas City, Kansas, United States
RecruitingTeva Investigational Site 15549
New York, New York, United States
RecruitingTeva Investigational Site 15551
New York, New York, United States
RecruitingTeva Investigational Site 15553
Durham, North Carolina, United States
RecruitingTeva Investigational Site 15548
Pittsburgh, Pennsylvania, United States
RecruitingTeva Investigational Site 15543
Spokane, Washington, United States
Recruiting
31 sites outside the US
Teva Investigational Site 35290
Bordeaux, France
RecruitingTeva Investigational Site 35289
Marseille, France
RecruitingTeva Investigational Site 35291
Paris, France
RecruitingTeva Investigational Site 35292
Toulouse, France
RecruitingTeva Investigational Site 32818
Dresden, Germany
RecruitingTeva Investigational Site 32822
Düsseldorf, Germany
RecruitingTeva Investigational Site 32825
Kassel, Germany
RecruitingTeva Investigational Site 32824
Marburg, Germany
RecruitingTeva Investigational Site 32820
München, Germany
RecruitingTeva Investigational Site 32819
Münster, Germany
RecruitingTeva Investigational Site 80203
Haifa, Israel
RecruitingTeva Investigational Site 80204
Tel Aviv, Israel
RecruitingTeva Investigational Site 30299
Bologna, Italy
RecruitingTeva Investigational Site 30297
Catania, Italy
RecruitingTeva Investigational Site 30298
Milan, Italy
RecruitingTeva Investigational Site 30294
Padova, Italy
RecruitingTeva Investigational Site 30296
Roma, Italy
RecruitingTeva Investigational Site 30295
Salerno, Italy
RecruitingTeva Investigational Site 84140
Chiba, Japan
RecruitingTeva Investigational Site 84139
Fuchū, Japan
RecruitingTeva Investigational Site 84137
Niigata, Japan
RecruitingTeva Investigational Site 84138
Sagamihara, Japan
RecruitingTeva Investigational Site 84141
Sanda-shi, Japan
RecruitingTeva Investigational Site 84135
Sendai, Japan
RecruitingTeva Investigational Site 31324
Barcelona, Spain
RecruitingTeva Investigational Site 31323
Barcelona, Spain
RecruitingTeva Investigational Site 31321
Barcelona, Spain
RecruitingTeva Investigational Site 31327
Madrid, Spain
RecruitingTeva Investigational Site 31320
Pamplona, Spain
RecruitingTeva Investigational Site 31322
Seville, Spain
RecruitingTeva Investigational Site 31319
Valencia, Spain
Recruiting
Study team
Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Study ID TV56286-NDG-20041
Study director
Teva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.