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

Acorda Therapeutics

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis, Acute Relapsing

Treatments: Drug: rHIgM22; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02398461

IM22-MS-1033

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

rHIgM22

Experimental group

Description:

Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).

Treatment:

Drug: rHIgM22

Placebo

Placebo Comparator group

Description:

Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).

Treatment:

Drug: Placebo