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NCT03345550 · ClinicalTrials.gov registry record · Phase 2
OPTIMA-TBI Pilot Study
A Phase 2 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT03345550: Clinical Trial Phase 2 study, sponsored by University of Michigan.
NCT03345550 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345550, a Phase 2 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.
Primary Outcome
Neuronal injury measured by Neurofilament Light Chain (NFL). Samples will be analyzed using a digital immunoassay based on a single molecule counting technology.
Interventions
- DRUG Placebo - Cap
- DRUG Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-09-12 |
| Est. Completion | 2021-07-27 |
| Phase | Phase 2 |
Why NCT03345550 stopped before completion
NCT03345550 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo - Cap is the first listed.
NCT03345550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03345550 about?
NCT03345550 is a clinical study titled "OPTIMA-TBI Pilot Study". This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.
What is the current status of trial NCT03345550?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2017-09-12. Estimated completion is 2021-07-27.
What interventions are being tested in trial NCT03345550?
The interventions under investigation include: Placebo - Cap (DRUG), Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules. (DRUG).
Who is sponsoring clinical trial NCT03345550?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03345550's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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