Trial · NCT04088630
Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
NCT04088630, Early phase 1, Completed, Wake Forest University Health Sciences; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage. Trials, record NCT04088630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04088630
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
- NCT number
- NCT04088630
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Intracerebral Hemorrhage, Cerebral Edema, Stroke Hemorrhagic, Intracerebral Hemorrhage, Hypertensive, Intracerebral Hemorrhage Intraparenchymal
- Interventions
- Fingolimod, Placebo, Open-label Fingolimod
- First posted
- 2019-09-13
- Last updated
- 2025-01-23
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Cardiac Events | up to 30 days post-ictus | Number of participants with clinically significant cardiac events. Clinically significant cardiac events include myocardial infarction, unstable angina, stroke, transient ischemic attack, any heart failure, bradycardia and heart block. Cardiac events were monitored with telemetry up to and after 72 hours while hospitalized. A check in was performed at 30 days with an in-person clinical or hospital visit to ascertain any cardiac events via patient discussion and medical record review. |
| Primary | Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | up to 90 days post-ictus | Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group |
| Primary | Rate of Neurologic Decline | up to 30 days post-ictus | considered a change ≥ 4 points of the NIHSS between enrollment and 30 days post-ictus. A higher score indicates higher severity and poorer prognosis. Scale is 0-42. |
| Secondary | Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube | Enrollment | Rate of successful administration of fingolimod through an NGT or Dobhoff tube in Open-label group only |
| Secondary | Percent Change in Lymphocyte Subpopulations of CD4+ T Cells | Enrollment to 30 days | Percent Change in Lymphocyte Subpopulations of CD4+ T Cells |
| Secondary | Percent Change in Lymphocyte Subpopulations of CD8+ T Cells | Enrollment and 30 days | Percent change in lymphocyte subpopulations of CD8+ T Cells |
| Secondary | Percent Change in Lymphocyte Subpopulations of CD19+ B Cells | Enrollment and 30 days | Percent change in lymphocyte subpopulations of CD19+ B cells |
| Secondary | Change in Hematoma Volume Obtained by MRI | Enrollment and 365 days | Average decrease per day by group in volumetric measurement calculations of hematoma obtained by MRI between enrollment and 365 days. All MRI imaging data obtained on hematoma volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject. |
| Secondary | Change in Hematoma Volume Obtained by CT | Enrollment and 365 days | Average decrease per day by group in volumetric measurement calculations of hematoma obtained by CT between enrollment and 365 days. All CT imaging data obtained on hematoma volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject. |
| Secondary | Change in Peri-hematomal Edema Volume Obtained by CT | Enrollment to 365 days | Average decrease per day by group in volumetric measurement calculations of peri-hematomal edema volume between enrollment and 365 days. All CT imaging data obtained on peri-hematomal edema volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinically Significant Cardiac Events | up to 30 days post-ictus | All enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | up to 90 days post-ictus | All enrolled participants by group | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Rate of Neurologic Decline | up to 30 days post-ictus | All three arms where data were available at 90 days | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube | Enrollment | 11 subjects enrolled in open-label arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Lymphocyte Subpopulations of CD4+ T Cells | Enrollment to 30 days | Subjects where 30 day labs were obtained are included in this analysis | percent change | MEDIAN |
| SECONDARY | Percent Change in Lymphocyte Subpopulations of CD8+ T Cells | Enrollment and 30 days | Subjects where 30 day labs were obtained are included in this analysis | percent change | MEDIAN |
| SECONDARY | Percent Change in Lymphocyte Subpopulations of CD19+ B Cells | Enrollment and 30 days | Subjects where 30 day labs were obtained are included in this analysis | percent change | MEDIAN |
| SECONDARY | Change in Hematoma Volume Obtained by MRI | Enrollment and 365 days | All enrolled subjects included in analysis. Fingolimod group included 18 observations, placebo included 14 observations and open-label included 23 observations across the time period. | mm^3 per day | MEAN |
| SECONDARY | Change in Hematoma Volume Obtained by CT | Enrollment and 365 days | All enrolled subjects included in analysis. Fingolimod group included 46 observations, placebo included 39 observations and open-label included 60 observations across the time period. | mm^3 per day | MEAN |
| SECONDARY | Change in Peri-hematomal Edema Volume Obtained by CT | Enrollment to 365 days | All enrolled subjects included in analysis. Fingolimod group included 46 observations, placebo included 39 observations and open-label included 60 observations across the time period. | mm^3 | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Cardiac Events | Fingolimod | 3 | Participants | ||
| Number of Participants With Clinically Significant Cardiac Events | Control | 0 | Participants | ||
| Number of Participants With Clinically Significant Cardiac Events | Open-label Fingolimod | 0 | Participants | ||
| Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | Fingolimod | 1 | Participants | ||
| Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | Control | 1 | Participants | ||
| Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | Open-label Fingolimod | 5 | Participants | ||
| Rate of Neurologic Decline | Fingolimod | 2 | Participants | ||
| Rate of Neurologic Decline | Control | 0 | Participants | ||
| Rate of Neurologic Decline | Open-label Fingolimod | 0 | Participants | ||
| Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube | Open-label Fingolimod | 11 | Participants |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod | 9 | |
| Overall Study | STARTED | Control | 8 | |
| Overall Study | STARTED | Open-label Fingolimod | 11 | |
| Overall Study | 24h Post-ictus | Fingolimod | 8 | |
| Overall Study | 24h Post-ictus | Control | 7 | |
| Overall Study | 24h Post-ictus | Open-label Fingolimod | 11 | |
| Overall Study | 72h Post-ictus | Fingolimod | 9 | |
| Overall Study | 72h Post-ictus | Control | 7 | |
| Overall Study | 72h Post-ictus | Open-label Fingolimod | 10 | |
| Overall Study | 5-7 Days | Fingolimod | 9 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Cardiac event | Cardiac disorders | Fingolimod | 3 | 9 | 3 |
| serious | Cardiac event | Cardiac disorders | Control | 0 | 8 | 0 |
| serious | Cardiac event | Cardiac disorders | Open-label Fingolimod | 0 | 11 | 0 |
| serious | Infection | Infections and infestations | Fingolimod | 1 | 9 | 1 |
| serious | Infection | Infections and infestations | Control | 1 | 8 | 1 |
| serious | Infection | Infections and infestations | Open-label Fingolimod | 5 | 11 | 5 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod | 3 | 9 |
| Total, all-cause mortality | Control | 1 | 8 |
| Total, all-cause mortality | Open-label Fingolimod | 1 | 11 |
| Total, other adverse events | Fingolimod | 0 | 9 |
| Total, other adverse events | Control | 0 | 8 |
| Total, other adverse events | Open-label Fingolimod | 0 | 11 |
| Total, serious adverse events | Fingolimod | 3 | 9 |
| Total, serious adverse events | Control | 1 | 8 |
| Total, serious adverse events | Open-label Fingolimod | 5 | 11 |
Source ClinicalTrials.gov
Papers84
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR001420 | Wake Forest Clinical and Translational Science Award | ROSENTHAL, GARY E; ARD, JAMY D; FOLEY, KRISTIE L | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2015 to 2023 |
Source NIH RePORTER
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.
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/NCT04088630
GET https://conductscience.org/api/trials/v1/NCT04088630/results?page=2