A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

NCT06422377 on ClinicalTrials.gov Phase 3 Takeda (industry) Started 2024-04-25 Terminated

Riskier than 16% of active trials

Model scores of the 29,894 trials active now.

Model score 10% 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 15% of the time (734 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2024-08-14, after 2024-04-25 start.

Reason given by the sponsor: “business”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2024-08-14. 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: purpose ofthe purposeis currentlytherapyexposed to
Phrases that lowered it: participantparticipantsand safetyefficacy andevaluate the
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 12.0% (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Drug's FAERS reports marked serious: 50% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 52 (lowers risk) · Sponsor's track record
Sponsor's past trials: 583 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Blinding: none (lowers risk) · Design
Minimum age: 2 (lowers risk) · Who can join
Maximum age: 65 (raises 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: 3 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 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: 583 (typical: 32)
Sponsor's past termination rate: 12.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 52 (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: 2 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: 50% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology
Drugs matched to FDA substances: soticlestat

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 Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome NCT05163314 · started 2022 · scored riskier than 53% of active trials terminated
A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome NCT04938427 · started 2021 · scored riskier than 62% of active trials completed
A Study of Soticlestat in Adults and Children With Rare Epilepsies NCT03635073 · started 2018 · scored riskier than 97% of active trials terminated
A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome NCT04940624 · started 2021 · scored riskier than 31% of active trials completed
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome NCT06118255 · started 2024 · scored riskier than 54% 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.