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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Teva Branded Pharmaceutical Products R&D LLC • ClinicalTrials.gov ID: NCT07197866

Registry updated: 2026-10-09
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Description

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.

Interventions

  • TEV-56286 (Drug)
    administered orally

Eligibility 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

Conditions

Multiple System Atrophy

Locations

  • Teva Investigational Site 15554 — La Jolla, California, United States
  • Teva Investigational Site 15544 — Boca Raton, Florida, United States
  • Teva Investigational Site 15555 — Tampa, Florida, United States
  • Teva Investigational Site 15550 — Chicago, Illinois, United States
  • Teva Investigational Site 15546 — Kansas City, Kansas, United States
  • Teva Investigational Site 15549 — New York, New York, United States
  • Teva Investigational Site 15551 — New York, New York, United States
  • Teva Investigational Site 15553 — Durham, North Carolina, United States
  • Teva Investigational Site 15548 — Pittsburgh, Pennsylvania, United States
  • Teva Investigational Site 15543 — Spokane, Washington, United States
  • Teva Investigational Site 35290 — Bordeaux, France
  • Teva Investigational Site 35289 — Marseille, France
  • Teva Investigational Site 35291 — Paris, France
  • Teva Investigational Site 35292 — Toulouse, France
  • Teva Investigational Site 32818 — Dresden, Germany
  • Teva Investigational Site 32822 — Düsseldorf, Germany
  • Teva Investigational Site 32825 — Kassel, Germany
  • Teva Investigational Site 32824 — Marburg, Germany
  • Teva Investigational Site 32820 — München, Germany
  • Teva Investigational Site 32819 — Münster, Germany
  • Teva Investigational Site 80203 — Haifa, Israel
  • Teva Investigational Site 80204 — Tel Aviv, Israel
  • Teva Investigational Site 30299 — Bologna, Italy
  • Teva Investigational Site 30297 — Catania, Italy
  • Teva Investigational Site 30298 — Milan, Italy
  • Teva Investigational Site 30294 — Padova, Italy
  • Teva Investigational Site 30296 — Roma, Italy
  • Teva Investigational Site 30295 — Salerno, Italy
  • Teva Investigational Site 84140 — Chiba, Japan
  • Teva Investigational Site 84139 — Fuchū, Japan
  • Teva Investigational Site 84137 — Niigata, Japan
  • Teva Investigational Site 84138 — Sagamihara, Japan
  • Teva Investigational Site 84141 — Sanda-shi, Japan
  • Teva Investigational Site 84135 — Sendai, Japan
  • Teva Investigational Site 31324 — Barcelona, Spain
  • Teva Investigational Site 31323 — Barcelona, Spain
  • Teva Investigational Site 31321 — Barcelona, Spain
  • Teva Investigational Site 31327 — Madrid, Spain
  • Teva Investigational Site 31320 — Pamplona, Spain
  • Teva Investigational Site 31322 — Seville, Spain
  • Teva Investigational Site 31319 — Valencia, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record