Botulinum Toxin Type A Block of the Otic Ganglion in Chronic Cluster Headache: Safety Issues
Model scores of the 29,894 trials active now.
Model score 16% 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 26% of the time (851 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-09-13, after 2017-04-18 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 2019-09-13. 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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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: patientslungmriimagingbrain
Phrases that lowered it: medicationweeks beforerelevantperiodeffect -
Phase: 1/2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports marked serious: 17.3% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 33 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 8.1% (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor's past trials: 197 (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
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Maximum age: 70 (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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 197 (typical: 32)
- Sponsor's past termination rate
- 8.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 33 (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
- 30675 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4874 (typical: 412.5)
- Drug's FAERS reports marked serious
- 17.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, dermatology
- Drugs matched to FDA substances
- botulinum toxin type a, idoxuridine
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
- Botox Injection in Treatment of Cluster Headache NCT02019017 · started 2013 · scored riskier than 66% of active trials completed
- Botox Injection in Treatment of Chronic Migraine NCT02259075 · started 2015 · scored riskier than 52% of active trials completed
- Follow the Sutures. A New Procedure for Injection of Botulinum Toxin for Chronic Migraine NCT03543254 · started 2018 · scored riskier than 38% of active trials completed
- Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine NCT04069897 · started 2019 · scored riskier than 35% of active trials completed
- Botulinum Toxin Type A in Treatment of Cranial Allodynia in Patients With Headache NCT01357798 · started 2010 · scored riskier than 34% 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.