A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
Model scores of the 29,894 trials active now.
Model score 12% 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 16% of the time (269 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-16, after 2022-05-19 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 2023-10-16. 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
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: definedprotocolkeynoncriteria for
Phrases that lowered it: to evaluatethe pastevaluate thestudy drugdose -
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: double (raises risk) · Design
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
-
Number of arms: 3 (lowers risk) · Design
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Maximum age: 65 (raises risk) · Who can join
-
Sponsor's past trials: 10 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Keywords listed: 3 (lowers risk) · Design
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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
- 2
- Number of arms
- 3 (typical: 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
- 3 (typical: 1)
Who can join
- Minimum age
- 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
- 10 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- none matched
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
- Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder NCT02067793 · started 2014 · scored riskier than 10% of active trials completed
- Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD) NCT01441440 · started 2011 · scored riskier than 13% of active trials completed
- Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD) NCT03785652 · started 2015 · scored riskier than 14% of active trials completed
- XEN1101 for Major Depressive Disorder NCT04827901 · started 2021 · scored riskier than 49% of active trials completed
- A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD NCT06236880 · started 2024 · scored riskier than 41% 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.