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

Description

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.

Study Start Date

April 2015

Estimated Completion Date

November 2016

Interventions

  • Drug: Placebo
  • Drug: rHIgM22

Specialties

  • Internal Medicine: Clinical Pharmacology,Neurology
  • Neurology: Demyelinating Disorders,Neuro/Psych pharmacology
  • Pharmacy: Neuro/Psych pharmacology

MeSH Terms

  • Demyelinating Autoimmune Diseases, CNS
  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting

Study ID

Acorda Therapeutics -- IM22-MS-1033

Status

Unknown

Trial ID

NCT02398461

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

30

Sponsor

Acorda Therapeutics

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (13)

Study Location Distance Name Phone Email
Acorda Site 17 - Providence, Rhode Island 42.6 miles None None None
Acorda Site 19 - Teaneck, New Jersey 181.8 miles Melvin Stacy 201-833-3000 None
Acorda Site 10 - Rochester, New York 335.8 miles Scheid Eileen 585-275-6673 None
Acorda Site 5 - Indianapolis, Indiana 805.0 miles None None None
Acorda Site 14 - Saint Louis, Missouri 1,049.0 miles PayneGates Delea 314-996-7775 None
Acorda Site 11 - Aurora, Colorado 1,759.8 miles Mary M Cook 303-724-7968 None
Acorda Site 16 - Centennial, Colorado 1,764.5 miles Getchell Leah 303-224-4672 None
Acorda Site 6 - Seattle, Washington 2,488.3 miles Courtney Yuriko 206-320-2200 None
Acorda Site 2 - Seattle, Washington 2,489.8 miles Chan Christine 206-342-6976 None
Acorda Site 12 - Long Beach, California 2,600.0 miles Mercado Minie 866-787-4257 None
Acorda Site 3 - Sacramento, California 2,628.4 miles Butters Janelle 916-734-6276 None
Acorda Site 15 - Stanford, California 2,694.5 miles Bernadette Gabriel 650-721-6188 None
Acorda Site 7 - San Francisco, California 2,696.4 miles Shum Nancy 415-502-7219 None

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