An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
NCT ID: NCT02398461
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2015-04-30
2017-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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rHIgM22
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).
rHIgM22
Administered via IV infusion
Placebo
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).
Placebo
Interventions
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rHIgM22
Administered via IV infusion
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
Acorda Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Acorda Site #2
Seattle, Washington, United States
Acorda Site #6
Seattle, Washington, United States
Countries
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References
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Greenberg BM, Bowen JD, Alvarez E, Rodriguez M, Caggiano AO, Warrington AE, Zhao P, Eisen A. A double-blind, placebo-controlled, single-ascending-dose intravenous infusion study of rHIgM22 in subjects with multiple sclerosis immediately following a relapse. Mult Scler J Exp Transl Clin. 2022 Apr 26;8(2):20552173221091475. doi: 10.1177/20552173221091475. eCollection 2022 Apr-Jun.
Other Identifiers
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IM22-MS-1033
Identifier Type: -
Identifier Source: org_study_id
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