A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

NCT03030599 on ClinicalTrials.gov Phase 3 Jazz Pharmaceuticals (industry) Started 2017-03-14 Completed

Riskier than 25% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 2% 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 2019-07-10, after 2017-03-14 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 2019-07-10. 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: treatedsubjectsafeplacebo controlledpresence of
Phrases that lowered it: and safetysafety ofefficacy andthe efficacyreceive
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 34.6% (lowers risk) · Drug's FDA history
Disease area, neurology: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 1.5% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 25 (lowers risk) · Sponsor's track record
Disease area, psychiatry: Yes (raises risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 85 (lowers risk) · Sponsor's track record
Maximum age: 70 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Responsible party: sponsor (lowers 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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 70 (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: 85 (typical: 32)
Sponsor's past termination rate: 7.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 25 (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: 36943 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 20002 (typical: 412.5)
Drug's FAERS reports marked serious: 34.6% (typical: 85.6%)
Drug's FAERS reports with a death: 1.5% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, psychiatry
Drugs matched to FDA substances: oxybate

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

Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy NCT02348593 · started 2015 · scored riskier than 13% of active trials completed
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension NCT03533114 · started 2018 · scored riskier than 43% of active trials completed
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) NCT06358950 · started 2024 · scored riskier than 29% of active trials completed
Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA NCT02348619 · started 2015 · scored riskier than 12% of active trials completed
A Study of TAK-861 in Participants With Narcolepsy Type 2 NCT05687916 · started 2023 · scored riskier than 54% 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.