Trial · NCT00904826

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

NCT00904826, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2013-11-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica. Trials, record NCT00904826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00904826

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica
NCT number: NCT00904826
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 14 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Neuromyelitis Optica, Devic's Disease
Interventions: Eculizumab
First posted: 2009-05-20
Last updated: 2013-11-04
Results first posted: 2013-11-04

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Median Number of Neuromyelitis Optica (NMO) Attacks Per Year	baseline, after 12 months of treatment
Secondary	Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment	12 months
Secondary	Change in Expanded Disability Status Scale (EDDS) Score	baseline, 12 months	The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.
Secondary	Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point	12 months	Visual acuity was measured using the the Visual Acuity subscale of the Opticospinal Impairment Score (OSIS) for Exacerbations. This subscale ranges from 0 (normal) to 8 (no light perception).
Secondary	Number of Subjects With Change in Ambulation by at Least 1 Point	12 months	Ambulation was measured by the Hauser Ambulation Index, which ranges from 0 (asymptomatic; fully active) to 9 (restricted to wheelchair; unable to transfer self independently.)
Secondary	Mean Serum Concentration of Eculizumab	6 weeks, 3 months, 6 months, 9 months, 12 months
Secondary	Percentage Hemolysis	baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months	Percentage of hemolysis is a measure of complement activity. Less than 20% lysis is deemed to be complete complement inhibition.
Secondary	Mean Eculizumab Concentration in Cerebrospinal Fluid (CSF)	3 months
Secondary	Mean Complement Protein 5 (C5) Concentration in CSF	baseline, 3 months

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Median Number of Neuromyelitis Optica (NMO) Attacks Per Year	baseline, after 12 months of treatment		attacks per year	MEDIAN
SECONDARY	Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment	12 months		participants	NUMBER
SECONDARY	Change in Expanded Disability Status Scale (EDDS) Score	baseline, 12 months		units on a scale	MEAN
SECONDARY	Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point	12 months		participants	NUMBER
SECONDARY	Number of Subjects With Change in Ambulation by at Least 1 Point	12 months		participants	NUMBER
SECONDARY	Mean Serum Concentration of Eculizumab	6 weeks, 3 months, 6 months, 9 months, 12 months	Patient 13 was excluded from the 3 months measurement because she had temporarily discontinued treatment.	micrograms/mL	MEAN
SECONDARY	Percentage Hemolysis	baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months	Subject 13 was excluded at 3 months visit because she had temporarily discontinued treatment.	percentage of hemolysis	MEAN
SECONDARY	Mean Eculizumab Concentration in Cerebrospinal Fluid (CSF)	3 months	12 subjects including subject 13 agreed to have CSF draw at the 3 month visit, but subject 13 was excluded because she had temporarily discontinued treatment.	ng/mL	MEAN
SECONDARY	Mean Complement Protein 5 (C5) Concentration in CSF	baseline, 3 months	At 3 months, C5 was undetectable in 6 subjects; patient 13 was excluded because she had temporarily discontinued treatment.	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group19

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Median Number of Neuromyelitis Optica (NMO) Attacks Per Year	Eculizumab	Baseline	3	Full Range 2 to 4	attacks per year
Median Number of Neuromyelitis Optica (NMO) Attacks Per Year	Eculizumab	After 12 months of treatment	0	Full Range 0 to 1	attacks per year
Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment	Eculizumab		2		participants
Change in Expanded Disability Status Scale (EDDS) Score	Eculizumab		-0.7	95% Confidence Interval -1.2 to -0.2	units on a scale
Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point	Eculizumab		5		participants
Number of Subjects With Change in Ambulation by at Least 1 Point	Eculizumab		3		participants
Mean Serum Concentration of Eculizumab	Eculizumab	6 weeks	206	Standard Deviation 77	micrograms/mL
Mean Serum Concentration of Eculizumab	Eculizumab	3 months	187	Standard Deviation 91.2	micrograms/mL
Mean Serum Concentration of Eculizumab	Eculizumab	9 months	230	Standard Deviation 85.3	micrograms/mL
Mean Serum Concentration of Eculizumab	Eculizumab	12 months	246	Standard Deviation 102	micrograms/mL

1 to 10 of 19Source ClinicalTrials.gov

See all 19 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Eculizumab	14
Overall Study	COMPLETED	Eculizumab	14
Overall Study	NOT COMPLETED	Eculizumab	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	General disorders	Eculizumab	9	14	23
other	Nausea	Gastrointestinal disorders	Eculizumab	6	14	18
other	Dizziness	General disorders	Eculizumab	6	14	13
other	Diarrhea	Gastrointestinal disorders	Eculizumab	6	14	7
other	Coughing	Respiratory, thoracic and mediastinal disorders	Eculizumab	5	14	6
other	Abdominal Pain	General disorders	Eculizumab	4	14	5
other	Rash	Skin and subcutaneous tissue disorders	Eculizumab	3	14	3
other	Muscle cramps	Musculoskeletal and connective tissue disorders	Eculizumab	2	14	9
other	Urinary tract infection	Infections and infestations	Eculizumab	2	14	6
other	Flu like symptoms	General disorders	Eculizumab	2	14	3

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Eculizumab
Total, other adverse events	Eculizumab	9	14
Total, serious adverse events	Eculizumab	1	14

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
15589308	BACKGROUND	PubMed
16087714	BACKGROUND	PubMed
16717206	BACKGROUND	PubMed
17706564	BACKGROUND	PubMed
17928579	BACKGROUND	PubMed
17989688	BACKGROUND	PubMed
19752309	BACKGROUND	PubMed
23623397	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00904826

GET https://conductscience.org/api/trials/v1/NCT00904826/registered

API reference For AI assistants