A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-05-22, after 2019-10-23 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2020-05-22. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: placeboheartcardiaccoronaryms
Phrases that lowered it: healthyperiodkgcrossoverthe effect -
Design: crossover (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 9.4% (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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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Maximum age: 55 (lowers risk) · Who can join
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Primary purpose: basic science (raises risk) · Design
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Drug's FAERS reports marked serious: 85.4% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 32
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 12786 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2567 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- moxifloxacin, padsevonil
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
- A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin NCT01756495 · started 2013 · scored riskier than 6% of active trials completed
- A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Participants NCT04013191 · started 2019 · scored riskier than 6% of active trials completed
- A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects NCT05758818 · started 2023 · scored riskier than 9% of active trials terminated
- A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers NCT01516372 · started 2012 · scored riskier than 2% of active trials completed
- A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants. NCT05878522 · started 2023 · scored riskier than 4% 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.