A Study in Healthy Male Volunteers to Investigate the Safety and Tolerability of a Single Dose of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine) for Brachial Plexus Blockade
Model scores of the 29,894 trials active now.
Model score 5% 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 8% of the time (544 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-09-21, after 2018-01-30 start.
Reason given by the sponsor: “efficacy”
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 2018-09-21. 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) (lowers risk) · Wording
Phrases that raised it: failurecellascendingoxygentolerability
Phrases that lowered it: healthykgthe investigatorbodythis trial -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 26.1% (raises risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Blinding: triple (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 9.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 67.1% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 4 (lowers risk) · Sponsor's track record
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Maximum age: 55 (lowers risk) · Who can join
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
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 46 (typical: 32)
- Sponsor's past termination rate
- 26.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 48066 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8828 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- bupivacaine, epinephrine
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
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- Thorough QT/QTc of Pritelivir in Healthy Subjects NCT05671029 · started 2022 · scored riskier than 5% of active trials completed
- A Study to Evaluate the Safety and Pharmacokinetics of NTM-1633 vs Placebo Administered Intravenously in Healthy Adults NCT03603665 · started 2018 · scored riskier than 6% of active trials completed
- Single or Repeat Dose of G03-52-01 in Adult Subjects NCT05348993 · started 2022 · scored riskier than 4% of active trials completed
- Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults NCT06444048 · started 2024 · scored riskier than 5% 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.