Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
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 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 2011-11-30, after 2008-10-31 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 2011-11-30. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Has a data monitoring committee: not given (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 10.3% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: long termthe longcellcarcinomaterm safety
Phrases that lowered it: efficacydrugsdrugkghistory -
Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 50 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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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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Drug's FAERS reports before start: 8707 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 64 (lowers risk) · Sponsor's track record
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Maximum age: 78 (raises 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 78 (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
- 64 (typical: 32)
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 50 (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
- 8707 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2016 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- carbamazepine, zonisamide
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 Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study) NCT01136954 · started 2008 · scored riskier than 18% of active trials completed
- Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy NCT00693017 · started 2008 · scored riskier than 37% of active trials terminated
- Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures NCT00692003 · started 2008 · scored riskier than 39% of active trials terminated
- Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study) NCT00566254 · started 2008 · scored riskier than 16% of active trials completed
- Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures NCT02535091 · started 2016 · scored riskier than 74% 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.