Extension to see if TEV-56286 can relieve Multiple System Atrophy symptoms
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
PHASE2 · Teva Branded Pharmaceutical Products R&D, Inc. · NCT07197866
This extension will test whether daily oral TEV-56286 is safe and helps adults with Multiple System Atrophy over about 100 weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. (industry) |
| Locations | 18 sites (Boca Raton, Florida and 17 other locations) |
| Trial ID | NCT07197866 on ClinicalTrials.gov |
What this trial studies
This open-label extension enrolls adults with MSA who completed the 48-week double-blind TEV-56286 trial and continues oral dosing to collect long-term safety and tolerability data. Participants will have regular clinic visits and safety monitoring during approximately 100 weeks of follow-up. The trial emphasizes recording adverse events, laboratory results, and adherence rather than demonstrating definitive efficacy. No new experimental procedures beyond continued study drug administration and routine safety assessments are planned.
Who should consider this trial
Good fit: Ideal candidates are adults with MSA who completed the parent double-blind trial to week 48, can comply with contraception requirements, and can attend visits at one of the sponsor's sites.
Not a fit: Patients who did not complete the parent trial, cannot meet contraception or follow-up requirements, or have significant comorbidities may not receive benefit from participating.
Why it matters
Potential benefit: If TEV-56286 proves safe and tolerable long-term, it could offer an oral treatment option that helps relieve MSA symptoms and support larger efficacy trials.
How similar studies have performed: There are few successful late-stage treatments for MSA to date, and while multiple small trials have tested symptomatic and disease-modifying approaches, the field remains largely unmet and TEV-56286 is a relatively novel candidate.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boca Raton, Florida and 17 other locations
- Teva Investigational Site 15544 — Boca Raton, Florida, United States (RECRUITING)
- Teva Investigational Site 15555 — Tampa, Florida, United States (RECRUITING)
- Teva Investigational Site 15549 — New York, New York, United States (RECRUITING)
- Teva Investigational Site 15551 — New York, New York, United States (RECRUITING)
- Teva Investigational Site 15543 — Spokane, Washington, United States (RECRUITING)
- Teva Investigational Site 35290 — Bordeaux, France (RECRUITING)
- Teva Investigational Site 35291 — Paris, France (RECRUITING)
- Teva Investigational Site 35292 — Toulouse, France (RECRUITING)
- Teva Investigational Site 32818 — Dresden, Germany (RECRUITING)
- Teva Investigational Site 32822 — Düsseldorf, Germany (RECRUITING)
- Teva Investigational Site 80203 — Haifa, Israel (RECRUITING)
- Teva Investigational Site 30299 — Bologna, Italy (RECRUITING)
- Teva Investigational Site 30295 — Salerno, Italy (RECRUITING)
- Teva Investigational Site 84137 — Niigata, Japan (RECRUITING)
- Teva Investigational Site 84141 — Sanda-shi, Japan (RECRUITING)
- Teva Investigational Site 31324 — Barcelona, Spain (RECRUITING)
- Teva Investigational Site 31323 — Barcelona, Spain (RECRUITING)
- Teva Investigational Site 31322 — Seville, Spain (RECRUITING)
Study contacts
- Study coordinator: Teva U.S. Medical Information
- Email: USMedInfo@tevapharm.com
- Phone: 1-888-483-8279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple System Atrophy