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NCT05323734 (Ganaxalone in Tuberous Sclerosis Complex related Epilepsy): BVCT ex-ante prediction vs. reported outcome

On 14 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 24 Oct 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05323734
Acronym
TrustTSC
Drug Name
Ganaxalone
Drug MoA
3beta-methylated synthetic analog of allopregnanolone
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Tuberous Sclerosis Complex related Epilepsy
Human Patients
128
Sponsor
Marinus Pharmaceuticals
Phase
Phase 3

Prediction of , index 1202

Prospective Prediction
Prediction Index
1202
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak additive clinical benefit in seizure frequency)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
102 days in advance
Readout Data Interpretation
ganaxolone did not meet the primary efficacy endpoint of seizure frequency despite numerical improvement (p=0.09)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults With Tuberous Sclerosis Complex (TSC)-Related Epilepsy (TrustTSC)
Phase
Phase 3
Status
Completed
Enrollment
129
Lead sponsor
Marinus Pharmaceuticals
Conditions
Tuberous Sclerosis Complex
Interventions
DRUG: Ganaxolone; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-04-01
Primary completion
2024-09-09
Completion
2024-10-14
Results first posted
2025-07-11
Primary outcomes
  • Percent Change From Baseline in 28-day Seizure Frequency for Primary Seizure Type During Double Blind Period (Baseline (Day 1), Day 28)

NCT05323734 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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