Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 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 2016-01-31, after 2013-02-28 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 2016-01-31. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: injurybrainrandomizationtraumaticdefined
Phrases that lowered it: investigatoropinioninterfere withclinicaldaily -
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
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 25.9% (raises risk) · Drug's FDA history
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Disease area, neurology: Yes (raises risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 16 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 96.6% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Maximum age: 75 (lowers risk) · Who can join
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Sponsor's past trials: 2 (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: 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
- 16 (typical: 18)
- Maximum age
- 75 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 116 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 39 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- glutamic acid, trofinetide
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 NNZ-2566 in Patients With Traumatic Brain Injury NCT00805818 · started 2010 · scored riskier than 63% of active trials completed
- Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI) NCT04677829 · started 2021 · scored riskier than 72% of active trials terminated
- A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI) NCT02100150 · started 2014 · scored riskier than 26% of active trials terminated
- Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury NCT05970575 · started 2023 · scored riskier than 46% of active trials terminated
- Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury NCT01143064 · started 2010 · scored riskier than 62% 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.