Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (289 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2015-11-11, after 2015-09-06 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 2015-11-11. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectpotentialtolerabilitysubjects withpregnancy
Phrases that lowered it: healthyscreeningperiodlabeltablet -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past trials: 2160 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
-
Design: single group (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 6.6% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports marked serious: 67.0% (lowers risk) · Drug's FDA history
-
Blinding: none (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 258 (raises risk) · Sponsor's track record
-
Drug's FAERS reports before start: 49640 (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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 2160 (typical: 32)
- Sponsor's past termination rate
- 5.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 258 (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
- 49640 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7203 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- lamotrigine
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
- The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg NCT02064465 · started 2014 · scored riskier than 2% of active trials completed
- Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions NCT06199791 · started 2023 · scored riskier than 2% of active trials completed
- Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China NCT01357902 · started 2011 · scored riskier than 1% of active trials completed
- Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects NCT01967771 · started 2013 · scored riskier than 3% of active trials completed
- The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects NCT01879423 · started 2013 · scored riskier than 1% 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.