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NCT05518578 (SPN-817 in Resistant Epilepsy): BVCT ex-ante prediction vs. reported outcome

On 11 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 23 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet commercially insufficient (high toxicity is usually not tolerated for anti-seizure medicine).

Clinical Trial

NCTID
NCT05518578
Acronym
RENAISSANCE
Drug Name
SPN-817
Drug MoA
a novel synthetic form of Huperzine A; potentially as an acetylcholinesterase inhibitor and an NMDAR antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Resistant Epilepsy
Human Patients
35
Sponsor
Supernus Pharmaceuticals
Phase
Phase 2

Prediction of , index 1541

Prospective Prediction
Prediction Index
1541
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in motor seizure frequency reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
42 days in advance
Readout Data Interpretation
75% mean focal seizure reduction; 25% TEAE-related discontinuation; high efficacy and high toxicity.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet commercially insufficient (high toxicity is usually not tolerated for anti-seizure medicine)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
RENAISSANCE Study: A Phase 2, Multicenter, Open Label Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
Phase
Phase 2
Status
Recruiting
Enrollment
60
Lead sponsor
Supernus Pharmaceuticals, Inc.
Conditions
Epilepsy; Seizures, Epileptic
Interventions
DRUG: SPN-817
Design
Single group · None
Primary purpose
Treatment
Start
2023-02-07
Primary completion
2027-12-31
Completion
2027-12-31
Primary outcomes
  • Effects of SPN-817 on safety and tolerability (72 weeks)

NCT05518578 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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