A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects

NCT02972125 on ClinicalTrials.gov Phase 1 UCB Biopharma S.P.R.L. (industry) Started 2016-11-30 Completed

Riskier than 2% of active trials

Model scores of the 29,894 trials active now.

Model score 3% 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 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2017-03-31, after 2016-11-30 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 2017-03-31. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: subjectsubjectsany clinicallyability topsychiatric
Phrases that lowered it: healthytabletbioequivalenceopen labelmale
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Minimum age: 20 (lowers risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 7.1% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Maximum age: 55 (lowers risk) · Who can join
Blinding: none (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 72.3% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 13 (lowers risk) · Sponsor's track record
Disease area, psychiatry: No (lowers risk) · Disease area
Disease area, neurology: No (lowers risk) · Disease area

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: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 55 (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 4 (typical: 32)
Sponsor's past termination rate: 25% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 13 (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: 7801 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2102 (typical: 412.5)
Drug's FAERS reports marked serious: 72.3% (typical: 85.6%)
Drug's FAERS reports with a death: 7.1% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: lacosamide

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 Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects NCT03086382 · started 2017 · scored riskier than 2% of active trials completed
Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects NCT01986608 · started 2013 · scored riskier than 0% of active trials completed
A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects NCT03204474 · started 2017 · scored riskier than 1% of active trials completed
Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males NCT01375387 · started 2011 · scored riskier than 2% of active trials completed
Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study) NCT00985348 · started 2009 · scored riskier than 0% 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.