BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05107128 (SAGE-718 in Huntington's Disease): BVCT ex-ante prediction vs. reported outcome

On 20 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 20 Nov 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
NCT05107128
Acronym
DIMENSION
Drug Name
SAGE-718 (dalzanemdor)
Drug MoA
NMDAR PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Huntington's Disease
Human Patients
189
Sponsor
Sage Therapeutics
Phase
Phase 2

Prediction of , index 1383

Prospective Prediction
Prediction Index
1383
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
214 days in advance
Readout Data Interpretation
dalzanemdor failed to meet the primary efficacy endpoint
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 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease
Phase
Phase 2
Status
Completed
Enrollment
189
Lead sponsor
Supernus Pharmaceuticals, Inc.
Conditions
Huntington's Disease
Interventions
DRUG: SAGE-718; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-01-26
Primary completion
2024-09-04
Completion
2024-10-03
Results first posted
2025-09-05
Primary outcomes
  • Change From Baseline in the SDMT (Baseline, Day 84)

NCT05107128 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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