Safety and Efficacy Study in Adult Subjects With Acute Migraines
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 4% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-01-26, after 2017-07-18 start.
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 2018-01-26. 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: months priorcoronarypainprior tomigraine
Phrases that lowered it: moderatepatientsefficacydiabetesinterfere with -
Sponsor's past termination rate: 16.0% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past trials: 1663 (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Blinding: triple (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 141 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 75% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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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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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Maximum age: not given (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 1663 (typical: 32)
- Sponsor's past termination rate
- 16.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 141 (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
- 4 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- rimegepant
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
- Safety and Efficacy in Adult Subjects With Acute Migraines NCT03237845 · started 2017 · scored riskier than 87% of active trials completed
- Trial in Adult Subjects With Acute Migraines NCT03461757 · started 2018 · scored riskier than 70% of active trials completed
- Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults NCT03732638 · started 2018 · scored riskier than 76% of active trials completed
- Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine NCT04574362 · started 2020 · scored riskier than 70% of active trials completed
- Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine NCT06603623 · started 2024 · scored riskier than 32% 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.