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C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation

NCT01759602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-07-18

Study results available
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Summary

The overall objective is to evaluate the tolerability/safety and preliminary efficacy of CINRYZE® (C1 esterase inhibitor \[human\]) as add-on therapy for treatment of acute optic neuritis and/or transverse myelitis in NMO and NMOSD.

Primary Objective: To evaluate the safety and tolerability of 3-5 doses of 1000 - 2000 Units intravenous CINRYZE in NMO/NMOSD patients during an acute exacerbation.

Secondary Objectives:

* To determine the frequency of adverse events with CINRYZE in this patient population.
* To determine the effect of CINRYZE on NMO clinical scores (Expanded Disability Status Scale and Low Contrast Visual Acuity).
* To compare the change in MRI lesion size and extent following a course of CINRYZE.

Conditions

  • Neuromyelitis Optica

Interventions

DRUG

C1-esterase inhibitor (Cinryze)

Sponsors & Collaborators

  • ViroPharma

    collaborator INDUSTRY

  • Michael Levy

    lead OTHER

Principal Investigators

  • Michael Levy, MD, PhD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01759602 on ClinicalTrials.gov