Targeting GABA-A for the Treatment of Social Disability in Young Adults With Autism Spectrum Disorders: A Phase II Proof of Mechanism Trial

NCT01966679 on ClinicalTrials.gov Phase 2 University of California, Los Angeles (academic or other) Started 2013-10-31 Completed

Riskier than 8% of active trials

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 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 2015-07-31, after 2013-10-31 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 2015-07-31. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: braindsmas definednormaldisorder
Phrases that lowered it: healthyplaceboadultsvolunteersdouble
Sponsor's past termination rate: 5.5% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Disease area, psychiatry: Yes (raises risk) · Disease area
Blinding: quadruple (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 78 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Responsible party: principal investigator (lowers risk) · Design
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Sponsor's past trials: 182 (lowers risk) · Sponsor's track record
Maximum age: 35 (raises risk) · Who can join
Collaborators: 0 (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: 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: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 35 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 182 (typical: 32)
Sponsor's past termination rate: 5.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 78 (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: phenyl

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

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A Proof-of-Concept Study of Minocycline in Autism NCT04031755 · started 2019 · scored riskier than 17% of active trials completed
A Study to Evaluate ARD-501 in Patients With Autism Spectrum Disorder NCT06126653 · started 2024 · scored riskier than 10% 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
Arbaclofen in Children and Adolescents With ASD NCT03682978 · started 2019 · scored riskier than 31% 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.