BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05173012 (SAGE-324 in Essential Tremor): BVCT ex-ante prediction vs. reported outcome

On 15 Dec 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 24 Jul 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
NCT05173012
Acronym
KINETIC 2
Drug Name
SAGE-324
Drug MoA
steroid GABAAR PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Essential Tremor
Human Patients
147
Sponsor
Sage Therapeutics
Phase
Phase 2

Prediction of , index 1379

Prospective Prediction
Prediction Index
1379
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
222 days in advance
Readout Data Interpretation
endpoints not met.
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 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
Phase
Phase 2
Status
Completed
Enrollment
146
Lead sponsor
Sage Therapeutics
Conditions
Essential Tremor
Interventions
DRUG: SAGE-324; DRUG: SAGE-324 Matched Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-01-05
Primary completion
2024-05-02
Completion
2024-05-16
Results first posted
2025-05-16
Primary outcomes
  • Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (Upper Limb) Total Score on Day 91 in the Monotherapy Cohort (Baseline, Day 91)

NCT05173012 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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