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NCT05318937 (SAGE-718 in Parkinson Disease Cognitive Dysfunction): BVCT ex-ante prediction vs. reported outcome

On 15 Dec 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 17 Apr 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05318937
Acronym
PRECEDENT
Drug Name
SAGE-718
Drug MoA
NMDAR PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Parkinson Disease Cognitive Dysfunction
Human Patients
86
Sponsor
Sage Therapeutics
Phase
Phase 2

Prediction of , index 1380

Prospective Prediction
Prediction Index
1380
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
124 days in advance
Readout Data Interpretation
WAIS-IV primary efficacy endpoint not met
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of SAGE718 MoA that has been permanently corrected.
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment
Phase
Phase 2
Status
Completed
Enrollment
86
Lead sponsor
Supernus Pharmaceuticals, Inc.
Conditions
Parkinson Disease; Cognitive Dysfunction
Interventions
DRUG: SAGE-718-matching placebo; DRUG: SAGE-718
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-06-06
Primary completion
2024-01-17
Completion
2024-02-23
Results first posted
2025-02-06
Primary outcomes
  • Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score (Baseline, Day 42)

NCT05318937 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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