Vigabatrin Ph 1 Cocaine Interaction Study
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (651 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 2010-10-31, after 2008-02-29 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 2010-10-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: to determineintravenousplacebo controlleddetermine ifcentral
Phrases that lowered it: interactionbetween 18groupcocaineparallel -
Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 6.7% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 97.8% (raises risk) · Drug's FDA history
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Keywords listed: 14 (lowers risk) · Design
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Sponsor type: government (raises risk) · Sponsor's track record
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Sponsor's past trials: 161 (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 90 (lowers 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 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 14 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 161 (typical: 32)
- Sponsor's past termination rate
- 5.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 18 (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
- 90 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 20 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- vigabatrin
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
- Vigabatrin for Treatment of Cocaine Dependence NCT00611130 · started 2008 · scored riskier than 16% of active trials completed
- Vigabatrin for the Treatment of Cocaine Dependency NCT01281202 · started 2011 · scored riskier than 38% of active trials completed
- Vigabatrin for Cocaine and Alcohol Dependence NCT01335867 · started 2011 · scored riskier than 26% of active trials terminated
- Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study NCT02563769 · started 2016 · scored riskier than 20% of active trials completed
- Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin NCT02393599 · started 2015 · scored riskier than 8% 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.