A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures

NCT01713946 on ClinicalTrials.gov Phase 3 Novartis Pharmaceuticals (industry) Started 2013-04-29 Completed

Riskier than 80% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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 2017-10-25, after 2013-04-29 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 2017-10-25. 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) (raises risk) · Wording Phrases that raised it: randomizationacutesyndromeonsetheart
Phrases that lowered it: and safetyefficacy andsafety ofweeksthe efficacy
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 13.4% (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 29.3% (raises risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 91.0% (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: 65 (lowers 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: 3 (typical: 2)
Number of arms: 3 (typical: 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: 5 (typical: 1)

Who can join

Minimum age: 2 (typical: 18)
Maximum age: 65 (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: 500 (typical: 32)
Sponsor's past termination rate: 13.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 303 (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: 5503 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1841 (typical: 412.5)
Drug's FAERS reports marked serious: 91.0% (typical: 85.6%)
Drug's FAERS reports with a death: 29.3% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: everolimus

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

Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC) NCT01289912 · started 2011 · scored riskier than 96% of active trials completed
Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC) NCT01070316 · started 2010 · scored riskier than 95% of active trials completed
Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy NCT05323734 · started 2022 · scored riskier than 48% of active trials completed
Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy NCT05604170 · started 2022 · scored riskier than 38% of active trials terminated
Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma NCT00972335 · started 2010 · scored riskier than 76% of active trials terminated

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.