Bioavailability of LY03004 and Risperdal® Consta®
Model scores of the 29,894 trials active now.
Model score 10% 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 7% of the time (289 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-01-31, after 2014-09-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2015-01-31. 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
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: patients muststableschizophreniaivprior
Phrases that lowered it: bioavailabilitylabelopenevaluate thefemale -
Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 65 (raises risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
-
Responsible party: sponsor (lowers risk) · Design
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Keywords listed: 0 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 6 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
-
Sponsor's past trials: 3 (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- 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
- 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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- An Randomized Open-Label PK Study of LY03004 Compared to Risperdal® Consta® in Stable Patients With Schizophrenia or Schizoaffective Disorder NCT02186769 · started 2014 · scored riskier than 12% of active trials completed
- Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder NCT02055287 · started 2013 · scored riskier than 17% of active trials completed
- Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients NCT04572685 · started 2020 · scored riskier than 11% of active trials completed
- Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia NCT02411526 · started 2015 · scored riskier than 5% of active trials completed
- Relative Bioavailability of LY03010 Compared to Listed Drug NCT04922593 · started 2021 · scored riskier than 6% 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.