Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414954
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-10
Brief Title:
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
Sponsor:
NMD Pharma AS
Organization:
NMD Pharma AS
Study Overview
Official Title:
A Phase 2b Randomised Double-Blind Placebo-Controlled Study to Evaluate the Efficacy Safety and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChRMuSK-Ab Myasthenia Gravis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SYNAPSE-MG
Brief Summary:
This Phase 2 proof-of-concept dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK administered twice a day BID for 21 days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507539-40 | OTHER | EUCTR | None |