Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine
Model scores of the 29,894 trials active now.
Model score 9% 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 (95 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 2014-11-30, after 2014-03-31 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 2014-11-30. 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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Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancersubject hasacutewomendefined
Phrases that lowered it: and safetyvisitsafety ofefficacy andsubjects -
Disease area, neurology: Yes (raises risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 65 (raises risk) · Who can join
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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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Keywords listed: 5 (lowers risk) · Design
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Drug's FAERS reports with a death: 13.0% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 94.1% (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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 2970 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 281 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- ketoprofen
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 Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain NCT03877718 · started 2019 · scored riskier than 30% of active trials completed
- Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine NCT01820559 · started 2009 · scored riskier than 9% of active trials completed
- MLD10 in the Prevention of Migraine in Adults NCT02322333 · started 2015 · scored riskier than 51% of active trials completed
- Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine NCT03700320 · started 2018 · scored riskier than 22% 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
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.