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NCT04088630 · ClinicalTrials.gov registry record · Early Phase 1
Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
A Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
NCT04088630: Completed Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT04088630 is a Early Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 28 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04088630, a Early Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and effectiveness of a single dose of fingolimod in patients with primary spontaneous intracerebral hemorrhage (ICH).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Fingolimod
- DRUG Open-label Fingolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2024-06-05 |
| Phase | Early Phase 1 |
What the finished NCT04088630 record still lists
NCT04088630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04088630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04088630 about?
NCT04088630 is a clinical study titled "Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage". The purpose of this study is to test the safety and effectiveness of a single dose of fingolimod in patients with primary spontaneous intracerebral hemorrhage (ICH).
What is the current status of trial NCT04088630?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2020-08-07. Estimated completion is 2024-06-05.
What interventions are being tested in trial NCT04088630?
The interventions under investigation include: Placebo (DRUG), Fingolimod (DRUG), Open-label Fingolimod (DRUG).
Who is sponsoring clinical trial NCT04088630?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04088630's enrollment target sits among peer trials
28 938th of 2000 higher than 1,039 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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