A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 4% 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
Completed on 2015-10-31, after 2013-09-30 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 2015-10-31. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: stablereceivingpriorivdepressive
Phrases that lowered it: mildparticipantasthmascreeningand safety -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Collaborators: 5 (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: quadruple (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Maximum age: 17 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 18.0% (lowers risk) · Drug's FDA history
-
Disease area, neurology: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Minimum age: 6 (lowers risk) · Who can join
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
- 5 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 6 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 111 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 27 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- riluzole
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 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder NCT05067582 · started 2022 · scored riskier than 15% of active trials completed
- Lurasidone Pediatric Autism Study NCT01911442 · started 2013 · scored riskier than 13% of active trials completed
- Targeting GABA-A for the Treatment of Social Disability in Young Adults With Autism Spectrum Disorders: A Phase II Proof of Mechanism Trial NCT01966679 · started 2013 · scored riskier than 8% of active trials completed
- A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) NCT04299464 · started 2021 · scored riskier than 65% of active trials completed
- A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism (MEM) NCT01372449 · started 2011 · scored riskier than 34% 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.