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Effectiveness of Zonisamide in Alcohol Dependent Veterans

NCT02368431 on ClinicalTrials.gov Phase 3 VA Office of Research and Development (government) Started 2015-03-01 Terminated
Riskier than 19% of active trials
this trial: 11% 0% 36%

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 11% of the time (234 trials).

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

How it ended

Terminated on 2018-10-01, after 2015-03-01 start.

Reason given by the sponsor: “business”

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

0% 19% 38% 57% 77% 0123456 yr completed 67% terminated 16%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-10-01. 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

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
2
Allocation
randomized
Design
parallel
Primary purpose
treatment
Blinding
quadruple (typical: none)
Has a data monitoring committee
Yes (typical: 56% yes)
Responsible party
sponsor
Collaborators
0
Keywords listed
7 (typical: 1)

Who can join

Minimum age
21 (typical: 18)
Maximum age
70 (typical: 71)
Sex
all
Accepts healthy volunteers
No (typical: 9% yes)

Sponsor's track record

Sponsor type
government (typical: academic or other)
Sponsor's past trials
172 (typical: 32)
Sponsor's past termination rate
7.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
154 (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
2337 (typical: 2148)
Drug's FAERS reports in the prior 12 months
630 (typical: 412.5)
Drug's FAERS reports marked serious
85.3% (typical: 85.6%)
Drug's FAERS reports with a death
9.6% (typical: 15.9%)

Disease area and drugs

Disease areas
psychiatry
Drugs matched to FDA substances
zonisamide

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

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.