Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 1% 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 2024-04-30, after 2019-08-26 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 2024-04-30. 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: onsetcardiackeybaselineevidence
Phrases that lowered it: evaluate theand safetyto evaluatesafety ofperiod -
Sponsor's past termination rate: 14.9% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports marked serious: 15.3% (lowers risk) · Drug's FDA history
-
Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor's past trials: 1250 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 0.6% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 159 (lowers risk) · Sponsor's track record
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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
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
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Disease area, respiratory: Yes (raises risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 14723 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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
- Yes (typical: 56% yes)
- Responsible party
- 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
- 1250 (typical: 32)
- Sponsor's past termination rate
- 14.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 159 (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
- 14824 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 14723 (typical: 412.5)
- Drug's FAERS reports marked serious
- 15.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, respiratory, immunology
- Drugs matched to FDA substances
- erenumab
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 Controlled Trial of Erenumab in Migraine Prevention NCT03812224 · started 2019 · scored riskier than 19% of active trials completed
- A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention NCT02066415 · started 2014 · scored riskier than 23% of active trials completed
- Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention NCT02456740 · started 2015 · scored riskier than 19% of active trials completed
- Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients NCT01688739 · started 2012 · scored riskier than 7% of active trials completed
- Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients NCT01723514 · started 2012 · scored riskier than 17% 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.