NCT01803867

An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all clinical presentations of MS.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	rHIgM22	Administered via IV infusion

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-10-01
• Completion: 2015-01-01
• First posted: 2013-03-04
• Last updated: 2015-02-27

Locations

17 sites across 1 country: United States