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Eligibility
for people ages 18 years to 70 years
Location
at Sacramento, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

Keywords

Multiple Sclerosis, Acute Relapsing

Eligibility

You can join if…

Open to people ages 18 years to 70 years

  • Males or females (18-70 years of age; < 104 kg)
  • Capable of giving informed consent
  • Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
  • Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
  • Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.

You CAN'T join if...

  • Certain specified co-morbidities (including pregnancy)
  • Taking certain proscribed medications
  • A medical regimen that has changed in the month prior to screening
  • Inability to undergo requisite MRI evaluations
  • Drug or alcohol abuse
  • Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.

Locations

  • Acorda Site #3 accepting new patients
    Sacramento, California, 95817, USA
  • Acorda Site #7 accepting new patients
    San Francisco, California, 94158, USA
  • Acorda Site #15 withdrawn
    Stanford, California, 94305, USA
  • Acorda Site #12 accepting new patients
    Long Beach, California, 90806, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acorda Therapeutics
ID
NCT02398461
Phase
Phase 1
Lead Scientist
Bruce Cree
Study Type
Interventional
Last Updated
October 2016
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