A Folinic Acid Intervention for Autism Spectrum Disorders
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (407 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
Terminated on 2015-11-30, after 2012-05-31 start.
Reason given by the sponsor: “other”
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 2015-11-30. 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: diagnosiskidneydisordersyndromedisease
Phrases that lowered it: trialchildrenongoingacidpi -
Sponsor's past termination rate: 22.2% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Blinding: quadruple (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
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Minimum age: 3 (lowers risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 25 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 17.6% (lowers risk) · Drug's FDA history
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Maximum age: 14 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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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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Collaborators: 1 (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 87.5% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 63 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 3 (typical: 18)
- Maximum age
- 14 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 63 (typical: 32)
- Sponsor's past termination rate
- 22.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 25 (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
- 7980 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1371 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- leucovorin
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
- Micronutrient Supplementation in Children With ASD NCT05268744 · started 2022 · scored riskier than 56% of active trials completed
- Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder NCT01745497 · started 2012 · scored riskier than 33% of active trials completed
- AFQ056 for Language Learning in Children With FXS NCT02920892 · started 2017 · scored riskier than 30% of active trials completed
- Folinic Acid in Autism NCT03771560 · started 2018 · scored riskier than 35% of active trials completed
- A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD NCT01661855 · started 2013 · scored riskier than 13% 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.