This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
Model scores of the 29,894 trials active now.
Model score 7% 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 8% of the time (544 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 2015-05-26, after 2014-06-05 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 2015-05-26. 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 hasany clinicallymultiplesubject isheart
Phrases that lowered it: effect ofthe effectsubjectsdrugcrossover -
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 7.8% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 35 (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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Blinding: quadruple (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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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 55 (lowers risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Keywords listed: 2 (raises 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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (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
- 115 (typical: 32)
- Sponsor's past termination rate
- 7.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 35 (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
- neurology, 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
- A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1 NCT06462404 · started 2024 · scored riskier than 13% of active trials completed
- Study for Naltrexone on the Abuse Potential of Methylphenidate NCT03769064 · started 2018 · scored riskier than 5% of active trials completed
- Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days NCT04971109 · started 2022 · scored riskier than 6% of active trials completed
- A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder NCT05594589 · started 2022 · scored riskier than 20% of active trials completed
- Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women NCT00940550 · started 2009 · scored riskier than 4% 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.