Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Model scores of the 29,894 trials active now.
Model score 13% 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 8% of the time (544 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-12-14, after 2019-05-03 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 2022-12-14. 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: extension studytolerabilitysubjects withcompletedsyndrome
Phrases that lowered it: openlabeladultdrugcriteria in -
Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 0% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 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 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- not given (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
- 23 (typical: 32)
- Sponsor's past termination rate
- 8.7% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- carisbamate
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
- Cenobamate Open-Label Extension Study for YKP3089C025 NCT03961568 · started 2019 · scored riskier than 88% of active trials completed
- Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs NCT01405053 · started 2011 · scored riskier than 39% of active trials completed
- A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome NCT03355209 · started 2017 · scored riskier than 21% of active trials completed
- A Long Term Extension Study of E2080 in Lennox-Gastaut Patients NCT01151540 · started 2010 · scored riskier than 9% of active trials completed
- Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome NCT03731715 · started 2019 · scored riskier than 14% 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.