Repeat Dose Safety Study of NRL-1 in Epilepsy Subjects
Model scores of the 29,894 trials active now.
Model score 14% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-07-23, after 2016-04-11 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 2020-07-23. 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: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectssubjectseizuresseizureepilepsy
Phrases that lowered it: safety ofthe investigatorevaluate theto evaluatethe trial -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 21.8% (raises risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Maximum age: 65 (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
- 1 (typical: 2)
- Allocation
- not applicable (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
- 2 (typical: 1)
Who can join
- Minimum age
- 6 (typical: 18)
- Maximum age
- 65 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 47193 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7608 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- diazepam
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
- Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects NCT02724423 · started 2016 · scored riskier than 12% of active trials completed
- Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy NCT03222349 · started 2017 · scored riskier than 11% of active trials completed
- Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy NCT03428360 · started 2018 · scored riskier than 20% 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
- Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures NCT01921205 · started 2013 · scored riskier than 51% 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.