Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-07 @ 7:20 AM
Study NCT ID:
NCT02398461
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2015-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
Sponsor:
Acorda Therapeutics
Organization:
Study Overview
Official Title:
A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: