Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535609
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2020-08-27
Brief Title:
An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar REN001 in Primary Mitochondrial Myopathy Patients
Sponsor:
Reneo Pharma Ltd
Organization:
Reneo Pharma Ltd
Study Overview
Official Title:
A Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With REN001 in Patients With Primary Mitochondrial Myopathy
Status:
COMPLETED
Status Verified Date:
2024-04
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:
STRIDE
Brief Summary:
This is a randomized double-blind placebo-controlled parallel group multi-centre study designed to investigate the efficacy and safety of REN001 administered once daily over a 24-week period to patients with PMM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None