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

Teva Branded Pharmaceutical Products R&D LLC

Status and phase: Enrolling; Phase 2

Conditions: Multiple System Atrophy

Treatments: Drug: TEV-56286

Study type: Interventional

Funder types: Industry

Identifiers

NCT07197866

2025-521642-14-00 (EU Trial (CTIS) Number)

TV56286-NDG-20041

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

TEV-56286

Experimental group

Treatment:

Drug: TEV-56286