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An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse | Clinical Trials | Clareo Health

COMPLETEDPHASE1

An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

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

NCT02398461•Acorda Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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 (12)

Acorda Site #12

Long Beach, California, United States

Acorda Site #3

Sacramento, California, United States

Acorda Site #7

San Francisco, California, United States

Acorda Site #11

Aurora, Colorado, United States

Acorda Site #16

Centennial, Colorado, United States

Acorda Site #22

Chicago, Illinois, United States

Acorda Site #14

St Louis, Missouri, United States

Acorda Site #19

Teaneck, New Jersey, United States

Acorda Site #10

Rochester, New York, United States

Acorda Site #18

Dallas, Texas, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

September 1, 2017

Completion Date

September 21, 2017

Last Updated

August 22, 2018

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis, Acute Relapsing

Interventions

rHIgM22

DRUG

Placebo

DRUG