Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-01-28, after 2021-05-19 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 2025-01-28. 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: sclerosisseizuresto assesssyndromethe investigator
Phrases that lowered it: participantparticipantsaminotransferaseefficacyalt -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 9.9% (raises risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports marked serious: 42.5% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 4.1% (lowers risk) · Drug's FDA history
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
-
Keywords listed: 22 (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 0.08 (lowers risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
-
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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 22 (typical: 1)
Who can join
- Minimum age
- 0.08 (typical: 18)
- Maximum age
- 1.92 (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
- 111 (typical: 32)
- Sponsor's past termination rate
- 9.9%
- Trials the sponsor started in the prior 2 years
- 17 (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
- 9099 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3804 (typical: 412.5)
- Drug's FAERS reports marked serious
- 42.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology
- Drugs matched to FDA substances
- cannabidiol
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 for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults NCT02224560 · started 2015 · scored riskier than 16% 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
- 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
- A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) NCT02544763 · started 2016 · scored riskier than 26% of active trials completed
- A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults NCT02224690 · started 2015 · scored riskier than 18% 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.