Fenfluramine for Adult Dravet Patients
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (276 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-05-13, after 2023-01-11 start.
Reason given by the sponsor: “enrollment”
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 2025-05-13. 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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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.2% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: kgepilepsyseizurestreatment ofrenal disease
Phrases that lowered it: participanttrialparticipants28and safety -
Drug's FAERS reports marked serious: 46.2% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 104 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 2.6% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 1 (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 509 (typical: 32)
- Sponsor's past termination rate
- 11.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 104 (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
- 1376 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 813 (typical: 412.5)
- Drug's FAERS reports marked serious
- 46.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- fenfluramine
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
- Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures NCT05288283 · started 2022 · scored riskier than 36% of active trials terminated
- CX-8998 for Absence Seizures NCT03406702 · started 2018 · scored riskier than 68% of active trials completed
- Study of EQU-001 for Uncontrolled Focal Onset Seizures NCT05473442 · started 2022 · scored riskier than 46% of active trials terminated
- Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE NCT05226780 · started 2022 · scored riskier than 62% of active trials terminated
- Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures NCT00699972 · started 2008 · scored riskier than 58% 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.