Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568237
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy Safety and Efficacy Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-centered Double-blind Randomized Placebo-controlled Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPAS-MSA
Brief Summary:
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy MSA
A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286
Another secondary objective is to evaluate the safety and tolerability of TEV-56286
The planned study period per participant is 56 weeks including a screening period up to 4 weeks a 48-week double-blind treatment period and a follow-up visit approximately 4 weeks after the end of the double-blind treatment period The study duration will be approximately 27 months
A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286
Another secondary objective is to evaluate the safety and tolerability of TEV-56286
The planned study period per participant is 56 weeks including a screening period up to 4 weeks a 48-week double-blind treatment period and a follow-up visit approximately 4 weeks after the end of the double-blind treatment period The study duration will be approximately 27 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None