Trial · NCT01759602
C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation
NCT01759602, Phase 1, Completed, Michael Levy; results first posted 2014-07-18
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation. Trials, record NCT01759602. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01759602
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation
- NCT number
- NCT01759602
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Michael Levy
- Conditions
- Neuromyelitis Optica
- Interventions
- C1-esterase inhibitor (Cinryze)
- First posted
- 2013-01-03
- Last updated
- 2014-07-18
- Results first posted
- 2014-07-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Safety Events During Hospitalization | 5-21 days | Over the course of hospitalization for the acute NMO exacerbations, subjects will be monitored daily for frequency of adverse events. |
| Secondary | Frequency of Serious Adverse Events. | 5-21 days | |
| Secondary | Percentage of Subjects Withdrawing Due to Adverse Events. | 5-21 days | |
| Secondary | Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters. | 5-21 days | ALT elevations were considered "mild" if they rose to less than 4-fold baseline levels. |
| Secondary | Expanded Disability Status Score (EDSS) | participants were followed for the duration of hospital stay ranging from 5-21 days, an average of 13 days; EDSS assessment was administered at discharge | The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of patients with multiple sclerosis. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. In addition, it also provides eight subscale measurements called Functional System (FS) scores. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Safety Events During Hospitalization | 5-21 days | adverse safety events | NUMBER | |
| SECONDARY | Frequency of Serious Adverse Events. | 5-21 days | serious adverse events | NUMBER | |
| SECONDARY | Percentage of Subjects Withdrawing Due to Adverse Events. | 5-21 days | percentage of subjects withdrawing | NUMBER | |
| SECONDARY | Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters. | 5-21 days | participants | NUMBER | |
| SECONDARY | Expanded Disability Status Score (EDSS) | participants were followed for the duration of hospital stay ranging from 5-21 days, an average of 13 days; EDSS assessment was administered at discharge | EDSS scores | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adverse Safety Events During Hospitalization | C1-esterase Inhibitor (Cinryze) | 0 | adverse safety events | ||
| Frequency of Serious Adverse Events. | C1-esterase Inhibitor (Cinryze) | 0 | serious adverse events | ||
| Percentage of Subjects Withdrawing Due to Adverse Events. | C1-esterase Inhibitor (Cinryze) | 0 | percentage of subjects withdrawing | ||
| Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters. | C1-esterase Inhibitor (Cinryze) | ALT Level, mild elevation | 1 | participants | |
| Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters. | C1-esterase Inhibitor (Cinryze) | Hematology, abnormal | 0 | participants | |
| Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters. | C1-esterase Inhibitor (Cinryze) | Urinalysis, abnormal | 0 | participants | |
| Expanded Disability Status Score (EDSS) | C1-esterase Inhibitor (Cinryze) | 2.5 | Full Range 0 to 8 | EDSS scores |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | C1-esterase Inhibitor (Cinryze) | 10 | |
| Overall Study | COMPLETED | C1-esterase Inhibitor (Cinryze) | 10 | |
| Overall Study | NOT COMPLETED | C1-esterase Inhibitor (Cinryze) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | C1-esterase Inhibitor (Cinryze) | ||
| Total, other adverse events | C1-esterase Inhibitor (Cinryze) | 0 | 10 |
| Total, serious adverse events | C1-esterase Inhibitor (Cinryze) | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25191939 | DERIVED |
Source 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01759602
GET https://conductscience.org/api/trials/v1/NCT01759602/registered