A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
Model scores of the 29,894 trials active now.
Model score 15% 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 12% of the time (422 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-03-18, after 2022-03-21 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 2025-03-18. 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
-
Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 684 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 94 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: long termschizophreniaextensioncompletedterm safety
Phrases that lowered it: trialparticipantspatients whoparticipantsafety of -
Sponsor's past termination rate: 8.2% (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 51 (lowers risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 51 (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
- 684 (typical: 32)
- Sponsor's past termination rate
- 8.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 94 (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
- Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2) NCT04846881 · started 2021 · scored riskier than 44% of active trials completed
- CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia NCT04860830 · started 2021 · scored riskier than 62% of active trials completed
- Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1) NCT04846868 · started 2021 · scored riskier than 42% of active trials completed
- A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. NCT04115319 · started 2019 · scored riskier than 55% of active trials completed
- A Twelve Week, Open Label Extension Study in Patients With Schizophrenia NCT01566162 · started 2012 · scored riskier than 21% 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.