Multiple Sclerosis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT02398461

Recruitment Status:

Completed

Sponsor:

Acorda Therapeutics

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There are 12 Locations for this study

See Locations Near You

Acorda Site #12
Long Beach California, 90806, United States
Acorda Site #3
Sacramento California, 95817, United States
Acorda Site #7
San Francisco California, 94158, United States
Acorda Site #11
Aurora Colorado, 80045, United States
Acorda Site #16
Centennial Colorado, 80112, United States
Acorda Site #22
Chicago Illinois, 60612, United States
Acorda Site #14
Saint Louis Missouri, 63131, United States
Acorda Site #19
Teaneck New Jersey, 07666, United States
Acorda Site #10
Rochester New York, 14642, United States
Acorda Site #18
Dallas Texas, 75390, United States
Acorda Site #2
Seattle Washington, 98101, United States
Acorda Site #6
Seattle Washington, 98122, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT02398461

Recruitment Status:

Completed

Sponsor:


Acorda Therapeutics

How clear is this clinincal trial information?

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