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NCT04940624 (Soticlestat in Dravet Syndrome): BVCT ex-ante prediction vs. reported outcome

On 11 May 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and inferior to SoC.

Clinical Trial

NCTID
NCT04940624
Acronym
SKYLINE
Drug Name
Soticlestat
Drug MoA
CH24H inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Dravet Syndrome
Human Patients
144
Sponsor
Takeda Pharmaceutical / Ovid Therapeutics
Phase
Phase 3

Prediction of , index 1593

Prospective Prediction
Prediction Index
1593
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit with inferior-to-cannabidiol-or-fenfluramine efficacy in seizure frequency reduction)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit to SoC)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
37 days in advance
Readout Data Interpretation
primary endpoint not met despite meeting several secondary endpoints.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and inferior to SoC
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)
Phase
Phase 3
Status
Completed
Enrollment
144
Lead sponsor
Takeda
Conditions
Dravet Syndrome (DS)
Interventions
DRUG: Soticlestat; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-10-28
Primary completion
2024-04-11
Completion
2024-04-11
Results first posted
2025-01-01
Primary outcomes
  • Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Full Treatment Period (Baseline; Full Treatment Period: Weeks 1 to 16)
  • Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Maintenance Period (Baseline; Maintenance Period: Weeks 5 to 16)

NCT04940624 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials