TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 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 2009-08-31, 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 2009-08-31. 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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Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 3.4% (lowers risk) · Sponsor's track record
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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: evidenceischemicacutediseasevascular
Phrases that lowered it: asthmacrossovernasalto evaluateevaluate the -
Sponsor's past trials: 668 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 543 (raises risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Number of arms: 6 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 62.9% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 65 (raises risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports before start: 11223 (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
- 3 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 668 (typical: 32)
- Sponsor's past termination rate
- 3.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 543 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 11223 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2842 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- butalbital, naproxen, sumatriptan
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
- Treximet Early Intervention Adolescent Migraine NCT01016678 · started 2010 · scored riskier than 22% of active trials completed
- Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea NCT03185143 · started 2017 · scored riskier than 30% of active trials completed
- Migraine Study in Adolescent Patients NCT00843024 · started 2008 · scored riskier than 17% of active trials completed
- The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination NCT03194555 · started 2017 · scored riskier than 20% of active trials completed
- Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine NCT04818515 · started 2021 · scored riskier than 68% 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.