Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-01 @ 7:15 AM
Study NCT ID:
NCT07197866
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
Sponsor:
Teva Branded Pharmaceutical Products R&D LLC
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-521642-14-00 | CTIS | None | View |