CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Eculizumabdrug
Likely dose
Eculizumab 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00904826
NCT00904826Phase 2Completed
CompareCT.gov

An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica

Mayo Clinic·interventional·Posted May 20, 2009·Updated Nov 4, 2013

In Brief

A Phase 2 clinical trial evaluating Eculizumab for Neuromyelitis Optica and Devic's Disease. Completed, enrolled 14 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuromyelitis Optica, Devic's Disease
CountriesUnited States
CollaboratorsAlexion Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 20, 2009
Enrollment StartApr 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.1 years ago

Interventions

Eculizumabdrug

The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. The first infusion will be given at Mayo Clinic site; subsequent infusions will be administered in the subject's home by a company which will send a nurse to administer the infusion. Subjects will receive therapy for a total of 12 months.