Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males

NCT01375387 on ClinicalTrials.gov Phase 1 UCB Pharma (industry) Started 2011-03-31 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 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 2011-06-30, after 2011-03-31 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 2011-06-30. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: safety tolerabilitytolerability andplacebodouble blindrandomized double
Phrases that lowered it: healthymgjapanesesinglemale
Design: crossover (lowers risk) · Design
Primary purpose: not given (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports with a death: 5.2% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 64.2% (lowers risk) · Drug's FDA history
Maximum age: 45 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 156 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Disease area, psychiatry: No (lowers risk) · Disease area
Number of arms: 8 (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Blinding: double (raises risk) · Design

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: 8 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: not given (typical: treatment)
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 45 (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: 156 (typical: 32)
Sponsor's past termination rate: 7.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 20 (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: 1089 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 696 (typical: 412.5)
Drug's FAERS reports marked serious: 64.2% (typical: 85.6%)
Drug's FAERS reports with a death: 5.2% (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 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects NCT03204474 · started 2017 · scored riskier than 1% of active trials completed
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 Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects NCT02972125 · started 2016 · scored riskier than 2% of active trials completed
A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects NCT06556966 · started 2024 · scored riskier than 5% 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.