BioinvestGPT ApS · Research use only

NCT05364021 (LP352 in Developmental and Epileptic Encephalopathies): BVCT ex-ante prediction vs. reported outcome

On 2 Oct 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Jan 2024 readout is classified on the dashboard as False Negative (FN), a missed prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

Acronym
PACIFIC
Drug Name
LP352
Drug MoA
5HT2C superagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Developmental and Epileptic Encephalopathies
Human Patients
52
Sponsor
Longboard Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1259

Prospective Prediction
Prediction Index
1259
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
92 days in advance
Readout Data Interpretation
32.5% motor seizable frequency reduction compared with placebo.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal MoA modelling that has been permanently corrected.
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
False Negative (FN)

ClinicalTrials.gov record

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

Official title
Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-escalation Study to Investigate the Safety, Tolerability, PK, PD, and Exploratory Efficacy of LP352 in Subjects With Developmental and Epileptic Encephalopathies
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
52
Lead sponsor
Longboard Pharmaceuticals
Conditions
Developmental and Epileptic Encephalopathy; Dravet Syndrome; Lennox Gastaut Syndrome
Interventions
DRUG: LP352; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-03-03
Primary completion
2023-11-16
Completion
2023-11-20
Primary outcomes
  • Treatment-emergent Adverse Events (Baseline up to Day 75)
  • Columbia-Suicide Severity Rating Scale (C-SSRS) Response (Baseline up to Day 75)
  • Patient Health Questionnaire-9 Total Score and Question 9 Score (Baseline up to Day 75)
  • Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Treatment Period (Baseline up to Day 75)
  • Percent Change from Baseline in Observed Countable Motor Seizure Frequency (per 28 Days) During the Maintenance Period (Baseline up to Day 75)

NCT05364021 on ClinicalTrials.gov

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