Extension to see if TEV-56286 can relieve Multiple System Atrophy symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Teva Investigational Site 15554
  La Jolla, California, United States Recruiting
• Teva Investigational Site 15544
  Boca Raton, Florida, United States Recruiting
• Teva Investigational Site 15555
  Tampa, Florida, United States Recruiting
• Teva Investigational Site 15550
  Chicago, Illinois, United States Recruiting
• Teva Investigational Site 15546
  Kansas City, Kansas, United States Recruiting
• Teva Investigational Site 15549
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Teva U.S. Medical Information
• Email: USMedInfo@tevapharm.com
• Phone: 1-888-483-8279

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.