Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Model scores of the 29,894 trials active now.
Model score 10% 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 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 2013-10-31, after 2012-10-31 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 2013-10-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subject hasivstableacutedefined
Phrases that lowered it: hcvthe pharmacokineticshepatitispharmacokinetics ofevaluate the -
Sponsor's past termination rate: 16.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 13 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Maximum age: 60 (lowers risk) · Who can join
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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
- 1 (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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (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
- 49 (typical: 32)
- Sponsor's past termination rate
- 16.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 13 (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 in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant NCT02658357 · started 2015 · scored riskier than 15% of active trials completed
- Safety and Tolerability of Risperidone Implants NCT02773576 · started 2016 · scored riskier than 59% of active trials completed
- A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia NCT01592110 · started 2012 · scored riskier than 7% 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
- Single Ascending Dose Study of RBP-7000 NCT02768649 · started 2011 · scored riskier than 18% 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.