Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 3% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-05-25, after 2019-11-20 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 2020-05-25. 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
-
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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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 15.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, neurology: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: chronicsolutionsevereat timepressure
Phrases that lowered it: rhinitisthe effectmedical historyeffect ofmg -
Drug's FAERS reports marked serious: 93.3% (raises risk) · Drug's FDA history
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Primary purpose: treatment (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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Blinding: none (raises risk) · Design
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Maximum age: 60 (lowers risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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
- not given (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (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
- 4955 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 981 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- ketamine
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
- THINK Trial: Treatment of Headache With IntraNasal Ketamine: A Randomized Controlled Trial Evaluating the Efficacy of Intranasal Ketamine Versus Standard Therapy in the Management of Primary Headache Syndromes in the Emergency Department NCT03081416 · started 2016 · scored riskier than 17% of active trials completed
- Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of Cluster Headache NCT02381795 · started 2015 · scored riskier than 84% of active trials terminated
- A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine NCT03806595 · started 2019 · scored riskier than 28% of active trials completed
- Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia NCT02473016 · started 2015 · scored riskier than 59% of active trials completed
- The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine NCT02735343 · started 2016 · scored riskier than 56% of active trials terminated
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.