Pilot Study of VVD-101 for the Treatment of Delayed Alcohol-Induced Headaches
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 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 2016-01-31, after 2014-07-31 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 2016-01-31. 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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Sponsor's past termination rate: 28.6% (raises risk) · Sponsor's track record
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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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Phase: 2 (raises risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectriskchildbearing potentialhas historyof childbearing
Phrases that lowered it: alcoholsmokerdrugasthmaabuse -
Blinding: triple (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Keywords listed: 1 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports before start: 194733 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Sponsor's past trials: 7 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 70.9% (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 28.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 194733 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 30951 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- aspirin, 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
- 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
- Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine NCT02605174 · started 2016 · 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
- A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses. NCT00989625 · started 2008 · scored riskier than 5% 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.