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Clinical Trials in the USA / NCT07197866
Recruiting Phase 2

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

NCT07197866 · tracked via the Priya Life Science USA tracker
Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Phase
Phase 2
Started
2025-09-30
Last updated
2026-09-14

Condition(s) studied

Multiple System Atrophy

Investigational drug(s) / intervention(s)

TEV-56286

TEV-56286: administered orally

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
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: * 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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Teva Investigational Site 15554 La Jolla California Recruiting
Teva Investigational Site 15544 Boca Raton Florida Recruiting
Teva Investigational Site 15555 Tampa Florida Recruiting
Teva Investigational Site 15546 Kansas City Kansas Recruiting
Teva Investigational Site 15549 New York New York Recruiting
Teva Investigational Site 15551 New York New York Recruiting
Teva Investigational Site 15548 Pittsburgh Pennsylvania Recruiting
Teva Investigational Site 15543 Spokane Washington Recruiting
Teva Investigational Site 35290 Bordeaux France Recruiting
Teva Investigational Site 35289 Marseille France Not Yet 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 32825 Kassel Germany Recruiting
Teva Investigational Site 32824 Marburg Germany Recruiting
Teva Investigational Site 32820 München Germany Recruiting
Teva Investigational Site 32819 Münster Germany Recruiting
Teva Investigational Site 80203 Haifa Israel Recruiting
Teva Investigational Site 80204 Tel Aviv Israel Recruiting
Teva Investigational Site 30299 Bologna Italy Recruiting
Teva Investigational Site 30297 Catania Italy Recruiting
Teva Investigational Site 30298 Milan Italy Recruiting
Teva Investigational Site 30296 Roma Italy Recruiting
Teva Investigational Site 30295 Salerno Italy Recruiting
Teva Investigational Site 84139 Fuchū Japan Recruiting
Teva Investigational Site 84137 Niigata Japan Recruiting
Teva Investigational Site 84138 Sagamihara Japan Recruiting
Teva Investigational Site 84141 Sanda-shi Japan Recruiting
Teva Investigational Site 84135 Sendai Japan Recruiting
Teva Investigational Site 31324 Barcelona Spain Recruiting
Teva Investigational Site 31323 Barcelona Spain Recruiting
Teva Investigational Site 31321 Barcelona Spain Recruiting
Teva Investigational Site 31320 Pamplona Spain Recruiting
Teva Investigational Site 31322 Seville Spain Recruiting
Teva Investigational Site 31319 Valencia Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07197866 on ClinicalTrials.gov ↗ ← All trials in the USA