Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (121 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2019-07-31, after 2013-03-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-07-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: greaterlinetreatmentbrainsites
Phrases that lowered it: the efficacysubjectsrandomizedcontrolledto participate -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Collaborators: 6 (lowers risk) · Design
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Phase: 1/2 (raises risk) · Design
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Maximum age: 0.04 (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: sponsor investigator (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 11.1% (lowers risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Minimum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 89.5% (raises risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 6 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.04 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 19114 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4365 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- levetiracetam, phenobarbital
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study NCT02229123 · started 2018 · scored riskier than 56% of active trials completed
- Levetiracetam Treatment of Neonatal Seizures NCT02550028 · started 2015 · scored riskier than 14% of active trials terminated
- Dosing of Levetiracetam (Keppra) in Neonates NCT01239212 · started 2010 · scored riskier than 69% of active trials completed
- Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures NCT04320940 · started 2021 · scored riskier than 17% of active trials terminated
- Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures NCT01458522 · started 2012 · scored riskier than 45% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.